Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2026-03-13 @ 8:28 AM
Study NCT ID:
NCT02190604
Status:
TERMINATED
Last Update Posted:
2020-12-30
First Post:
2014-07-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}, {'id': 'D001229', 'term': 'Aspergillosis, Allergic Bronchopulmonary'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D055732', 'term': 'Pulmonary Aspergillosis'}, {'id': 'D001228', 'term': 'Aspergillosis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D008172', 'term': 'Lung Diseases, Fungal'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722274', 'term': 'icenticaftor'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '862-778-8300', 'title': 'Study Director', 'organization': 'Novartis'}, 'certainAgreement': {'otherDetails': "The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Part 1 Placebo', 'description': 'Part 1 Placebo', 'otherNumAtRisk': 16, 'otherNumAffected': 8, 'seriousNumAtRisk': 16, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Part 1 QBW251 10mg', 'description': 'Part 1 QBW251 10mg', 'otherNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Part 1 QBW251 25mg', 'description': 'Part 1 QBW251 25mg', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Part 1 QBW251 150mg', 'description': 'Part 1 QBW251 150mg', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Part 1 QBW251 300mg', 'description': 'Part 1 QBW251 300mg', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Part 1 QBW251 500mg', 'description': 'Part 1 QBW251 500mg', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Part 1 QBW251 500mg (Fed)', 'description': 'Part 1 QBW251 500mg (fed)', 'otherNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Part 1 QBW251 750mg', 'description': 'Part 1 QBW251 750mg', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Part 1 QBW251 1000mg', 'description': 'Part 1 QBW251 1000mg', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Part 2 Placebo', 'description': 'Part 2 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'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part 1 and 2:Number of Participants (Healthy Volunteers) With Reported Adverse Events Receiving QBW251', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '6', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '6', 'groupId': 'OG011'}, {'value': '10', 'groupId': 'OG012'}, {'value': '6', 'groupId': 'OG013'}, {'value': '6', 'groupId': 'OG014'}, {'value': '6', 'groupId': 'OG015'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 4: QBW251', 'description': 'Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG001', 'title': 'Part 1 Cohort 5: QBW251', 'description': 'Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG002', 'title': 'Part 1 Cohort 6: QBW251', 'description': 'Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG003', 'title': 'Part 1 Cohort 6: QBW251(Fed)', 'description': 'Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG004', 'title': 'Part 1 Cohort 7: QBW251', 'description': 'Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG005', 'title': 'Part 1 Cohort 8: QBW251', 'description': 'Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG006', 'title': 'Part 1 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG007', 'title': 'Part 2 Cohort 1: QBW251', 'description': 'Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG008', 'title': 'Part 2 Cohort 2: QBW251', 'description': 'Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG009', 'title': 'Part 2 Cohort 3: QBW251', 'description': 'Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG010', 'title': 'Part 2 Cohort 4: QBW251', 'description': 'Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG011', 'title': 'Part 2 Cohort 5: QBW251', 'description': 'Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG012', 'title': 'Part 2 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG013', 'title': 'Part 1 Cohort 1: QBW251', 'description': 'Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15'}, {'id': 'OG014', 'title': 'Part 1 Cohort 2: QBW251', 'description': 'Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG015', 'title': 'Part 1 Cohort 3: QBW251', 'description': 'Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}], 'classes': [{'title': 'Adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '4', 'groupId': 'OG005'}, {'value': '8', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '6', 'groupId': 'OG010'}, {'value': '4', 'groupId': 'OG011'}, {'value': '7', 'groupId': 'OG012'}, {'value': '3', 'groupId': 'OG013'}, {'value': '2', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Serious adverse events', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}, {'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}, {'value': '0', 'groupId': 'OG012'}, {'value': '0', 'groupId': 'OG013'}, {'value': '0', 'groupId': 'OG014'}, {'value': '0', 'groupId': 'OG015'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 36', 'description': 'All adverse events (in healthy volunteers) reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All treated subjects were included in the data analysis. Subjects were analyzed according to the study treatment(s) received.'}, {'type': 'PRIMARY', 'title': 'Part 3: Change in Lung Clearance Index (LCI) From Baseline to Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 Cohort 1: QBW251', 'description': '150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG001', 'title': 'Part 3 Cohort 2: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG002', 'title': 'Part 3 Cohort 3: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG003', 'title': 'Part 3 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.27', 'spread': '0.769', 'groupId': 'OG000'}, {'value': '-0.85', 'spread': '1.798', 'groupId': 'OG001'}, {'value': '-0.13', 'spread': '2.276', 'groupId': 'OG002'}, {'value': '0.28', 'spread': '1.959', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 15', 'description': 'Change in Lung Clearance Index (LCI) will be conducted according to international standards in cystic fibrosis patients. Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test, A reduction in mean change from baseline for LCI2.5 indicates improvement.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD) analysis set: All randomized patients were included in the PD analysis'}, {'type': 'PRIMARY', 'title': 'Part 3: Number of Participants (Patients) With Reported Adverse Events Receiving QBW251', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 Cohort 1: QBW251', 'description': '150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG001', 'title': 'Part 3 Cohort 2: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG002', 'title': 'Part 3 Cohort 3: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG003', 'title': 'Part 3 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}], 'classes': [{'title': 'Adverse Events (AE)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Serious Adverse Events (SAE)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Day 56', 'description': 'All adverse events and serious adverse events (in patients) reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set: All randomized patients were included in the safety analysis'}, {'type': 'SECONDARY', 'title': 'Part 3:Change in Forced Expiratory Volume in 1 Second (FEV1) at Day 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 Cohort 1: QBW251', 'description': '150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG001', 'title': 'Part 3 Cohort 2: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG002', 'title': 'Part 3 Cohort 3: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG003', 'title': 'Part 3 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.58', 'spread': '2.476', 'groupId': 'OG000'}, {'value': '5.99', 'spread': '1.648', 'groupId': 'OG001'}, {'value': '-1.16', 'spread': '1.059', 'groupId': 'OG002'}, {'value': '-1.46', 'spread': '1.229', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 15', 'description': 'Forced Expiratory Volume in 1 second (FEV1) will be measured via spirometer according to international standards. Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD) analysis set: All randomized patients were included in the PD analysis'}, {'type': 'SECONDARY', 'title': 'Part 3: Change in Cystic Fibrosis Questionnaire-Revised Reported Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 Cohort 1: QBW251', 'description': '150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG001', 'title': 'Part 3 Cohort 2: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG002', 'title': 'Part 3 Cohort 3: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG003', 'title': 'Part 3 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.06', 'spread': '6.872', 'groupId': 'OG000'}, {'value': '5.04', 'spread': '4.617', 'groupId': 'OG001'}, {'value': '-2.62', 'spread': '2.853', 'groupId': 'OG002'}, {'value': '-2.06', 'spread': '4.415', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 14', 'description': 'Change in Cystic Fibrosis Questionnaire data will be obtained from patient reported outcomes (CFQ-R PRO). Respiratory Domain, cores range from 0 to 100, with higher scores indicating better health, a change of 4 is considered clinically relevant', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacodynamics (PD) analysis set: All randomized patients were included in the PD analysis'}, {'type': 'SECONDARY', 'title': 'Part 1: AUC0-t in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '16', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1: QBW251', 'description': 'Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG001', 'title': 'Part 1 Cohort 2: QBW251', 'description': 'Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG002', 'title': 'Part 1 Cohort 3: QBW251', 'description': 'Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG003', 'title': 'Part 1 Cohort 4: QBW251', 'description': 'Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG004', 'title': 'Part 1 Cohort 5: QBW251', 'description': 'Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG005', 'title': 'Part 1 Cohort 6: QBW251', 'description': 'Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG006', 'title': 'Part 1 Cohort 6: QBW251(Fed)', 'description': 'Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG007', 'title': 'Part 1 Cohort 7: QBW251', 'description': 'Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG008', 'title': 'Part 1 Cohort 8: QBW251', 'description': 'Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG009', 'title': 'Part 1 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}], 'classes': [{'categories': [{'measurements': [{'value': '52.5', 'spread': '28.1', 'groupId': 'OG000'}, {'value': '73.7', 'spread': '51.8', 'groupId': 'OG001'}, {'value': '692', 'spread': '389', 'groupId': 'OG002'}, {'value': '1650', 'spread': '907', 'groupId': 'OG003'}, {'value': '5470', 'spread': '1070', 'groupId': 'OG004'}, {'value': '9450', 'spread': '1740', 'groupId': 'OG005'}, {'value': '7470', 'spread': '2190', 'groupId': 'OG006'}, {'value': '20200', 'spread': '11500', 'groupId': 'OG007'}, {'value': '35900', 'spread': '9100', 'groupId': 'OG008'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated', 'groupId': 'OG009'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 2-5)', 'description': 'Pharmacokinetics of QBW251 in plasma: area under the plasma concentration versus time curve from time zero to time of last measurable concentration (AUC0-t). In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the AUC0-t goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered)', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis.'}, {'type': 'SECONDARY', 'title': 'Part 1: Maximum Concentration (Cmax) in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1: QBW251', 'description': 'Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG001', 'title': 'Part 1 Cohort 2: QBW251', 'description': 'Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG002', 'title': 'Part 1 Cohort 3: QBW251', 'description': 'Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG003', 'title': 'Part 1 Cohort 4: QBW251', 'description': 'Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG004', 'title': 'Part 1 Cohort 5: QBW251', 'description': 'Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG005', 'title': 'Part 1 Cohort 6: QBW251', 'description': 'Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG006', 'title': 'Part 1 Cohort 6: QBW251(Fed)', 'description': 'Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG007', 'title': 'Part 1 Cohort 7: QBW251', 'description': 'Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG008', 'title': 'Part 1 Cohort 8: QBW251', 'description': 'Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}], 'classes': [{'categories': [{'measurements': [{'value': '21.1', 'spread': '11.9', 'groupId': 'OG000'}, {'value': '24.7', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '186', 'spread': '82.3', 'groupId': 'OG002'}, {'value': '459', 'spread': '267', 'groupId': 'OG003'}, {'value': '1110', 'spread': '330', 'groupId': 'OG004'}, {'value': '1910', 'spread': '413', 'groupId': 'OG005'}, {'value': '1090', 'spread': '449', 'groupId': 'OG006'}, {'value': '2680', 'spread': '1000', 'groupId': 'OG007'}, {'value': '4540', 'spread': '930', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)', 'description': 'Pharmacokinetics of QBW251 in plasma: observed maximum plasma concentration following administration of QBW251. In this analysis Cmax will be reported using blood samples taken on Days 1- 5 are from healthy volunteers', 'unitOfMeasure': 'ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 1: Time to Maximum Concentration (Tmax) in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1: QBW251', 'description': 'Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG001', 'title': 'Part 1 Cohort 2: QBW251', 'description': 'Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG002', 'title': 'Part 1 Cohort 3: QBW251', 'description': 'Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG003', 'title': 'Part 1 Cohort 4: QBW251', 'description': 'Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG004', 'title': 'Part 1 Cohort 5: QBW251', 'description': 'Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG005', 'title': 'Part 1 Cohort 6: QBW251', 'description': 'Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG006', 'title': 'Part 1 Cohort 6: QBW251(Fed)', 'description': 'Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG007', 'title': 'Part 1 Cohort 7: QBW251', 'description': 'Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG008', 'title': 'Part 1 Cohort 8: QBW251', 'description': 'Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.756', 'spread': '0.268', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '0.612', 'groupId': 'OG001'}, {'value': '1.33', 'spread': '0.516', 'groupId': 'OG002'}, {'value': '1.50', 'spread': '0.548', 'groupId': 'OG003'}, {'value': '1.50', 'spread': '0.837', 'groupId': 'OG004'}, {'value': '2.17', 'spread': '1.17', 'groupId': 'OG005'}, {'value': '3.40', 'spread': '0.894', 'groupId': 'OG006'}, {'value': '2.52', 'spread': '0.850', 'groupId': 'OG007'}, {'value': '1.83', 'spread': '0.753', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)', 'description': 'Pharmacokinetics of QBW251 in plasma: time to reach the maximum concentration after administration of QBW251. In this analysis Tmax will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In this part of the study a single dose was administered and samples were collected up to 5 days. As a result the Tmax is one value as the concentration-time curve goes to Day 5 (for some lower does QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered).', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 1: T1/2 in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1: QBW251', 'description': 'Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG001', 'title': 'Part 1 Cohort 2: QBW251', 'description': 'Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG002', 'title': 'Part 1 Cohort 3: QBW251', 'description': 'Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG003', 'title': 'Part 1 Cohort 4: QBW251', 'description': 'Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG004', 'title': 'Part 1 Cohort 5: QBW251', 'description': 'Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG005', 'title': 'Part 1 Cohort 6: QBW251', 'description': 'Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG006', 'title': 'Part 1 Cohort 6: QBW251(Fed)', 'description': 'Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG007', 'title': 'Part 1 Cohort 7: QBW251', 'description': 'Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG008', 'title': 'Part 1 Cohort 8: QBW251', 'description': 'Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'There were not enough time points to calculated the T1/2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'There were not enough time points to calculated the T1/2', 'groupId': 'OG001'}, {'value': '10.3', 'spread': '4.24', 'groupId': 'OG002'}, {'value': '10.1', 'spread': '3.35', 'groupId': 'OG003'}, {'value': '12.0', 'spread': '2.26', 'groupId': 'OG004'}, {'value': '12.7', 'spread': '1.99', 'groupId': 'OG005'}, {'value': '15.6', 'spread': '5.03', 'groupId': 'OG006'}, {'value': '12.8', 'spread': '3.85', 'groupId': 'OG007'}, {'value': '10.7', 'spread': '2.19', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)', 'description': 'Pharmacokinetics of QBW251 in plasma: terminal elimination half-life. In this analysis T1/2 will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the T1/2 goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered).', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 1: AUCinf in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1: QBW251', 'description': 'Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG001', 'title': 'Part 1 Cohort 2: QBW251', 'description': 'Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG002', 'title': 'Part 1 Cohort 3: QBW251', 'description': 'Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG003', 'title': 'Part 1 Cohort 4: QBW251', 'description': 'Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG004', 'title': 'Part 1 Cohort 5: QBW251', 'description': 'Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG005', 'title': 'Part 1 Cohort 6: QBW251', 'description': 'Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG006', 'title': 'Part 1 Cohort 6: QBW251(Fed)', 'description': 'Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG007', 'title': 'Part 1 Cohort 7: QBW251', 'description': 'Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG008', 'title': 'Part 1 Cohort 8: QBW251', 'description': 'Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient data', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient data', 'groupId': 'OG001'}, {'value': '731', 'spread': '387', 'groupId': 'OG002'}, {'value': '1680', 'spread': '903', 'groupId': 'OG003'}, {'value': '5510', 'spread': '1080', 'groupId': 'OG004'}, {'value': '9480', 'spread': '1740', 'groupId': 'OG005'}, {'value': '7540', 'spread': '2220', 'groupId': 'OG006'}, {'value': '20300', 'spread': '11500', 'groupId': 'OG007'}, {'value': '36000', 'spread': '9120', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)', 'description': 'Pharmacokinetics of QBW251 in plasma: area under the plasma concentration time curve from time zero to infinity. In this analysis AUCinf will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the AUCinf goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered)', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 1: CL/F in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1: QBW251', 'description': 'Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG001', 'title': 'Part 1 Cohort 2: QBW251', 'description': 'Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG002', 'title': 'Part 1 Cohort 3: QBW251', 'description': 'Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG003', 'title': 'Part 1 Cohort 4: QBW251', 'description': 'Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG004', 'title': 'Part 1 Cohort 5: QBW251', 'description': 'Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG005', 'title': 'Part 1 Cohort 6: QBW251', 'description': 'Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG006', 'title': 'Part 1 Cohort 6: QBW251(Fed)', 'description': 'Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG007', 'title': 'Part 1 Cohort 7: QBW251', 'description': 'Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG008', 'title': 'Part 1 Cohort 8: QBW251', 'description': 'Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient data', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient data', 'groupId': 'OG001'}, {'value': '123', 'spread': '49.0', 'groupId': 'OG002'}, {'value': '114', 'spread': '63.9', 'groupId': 'OG003'}, {'value': '56.2', 'spread': '11.0', 'groupId': 'OG004'}, {'value': '54.5', 'spread': '11.9', 'groupId': 'OG005'}, {'value': '71.6', 'spread': '22.6', 'groupId': 'OG006'}, {'value': '45.9', 'spread': '19.9', 'groupId': 'OG007'}, {'value': '29.7', 'spread': '9.00', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)', 'description': 'Pharmacokinetics of QBW251 in plasma: apparent systemic clearance from plasma following extravascular administration. In this analysis CL/F will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the CL/F goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered)', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 1: Vz/F in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '6', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 1 Cohort 1: QBW251', 'description': 'Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG001', 'title': 'Part 1 Cohort 2: QBW251', 'description': 'Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG002', 'title': 'Part 1 Cohort 3: QBW251', 'description': 'Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG003', 'title': 'Part 1 Cohort 4: QBW251', 'description': 'Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG004', 'title': 'Part 1 Cohort 5: QBW251', 'description': 'Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG005', 'title': 'Part 1 Cohort 6: QBW251', 'description': 'Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG006', 'title': 'Part 1 Cohort 6: QBW251(Fed)', 'description': 'Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG007', 'title': 'Part 1 Cohort 7: QBW251', 'description': 'Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'OG008', 'title': 'Part 1 Cohort 8: QBW251', 'description': 'Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient data', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient data', 'groupId': 'OG001'}, {'value': '1700', 'spread': '772', 'groupId': 'OG002'}, {'value': '1490', 'spread': '622', 'groupId': 'OG003'}, {'value': '957', 'spread': '151', 'groupId': 'OG004'}, {'value': '995', 'spread': '235', 'groupId': 'OG005'}, {'value': '1580', 'spread': '587', 'groupId': 'OG006'}, {'value': '827', 'spread': '375', 'groupId': 'OG007'}, {'value': '447', 'spread': '112', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)', 'description': 'Pharmacokinetics of QBW251 in plasma: apparent volume of distribution during the terminal elimination phase following extravascular administration. In this analysis Vz/F will be reported using blood samples taken on Days 1 - 5 from healthy volunteers.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 2: AUCtau in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Cohort 1: QBW251', 'description': 'Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG001', 'title': 'Part 2 Cohort 2: QBW251', 'description': 'Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG002', 'title': 'Part 2 Cohort 3: QBW251', 'description': 'Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG003', 'title': 'Part 2 Cohort 4: QBW251', 'description': 'Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG004', 'title': 'Part 2 Cohort 5: QBW251', 'description': 'Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}], 'classes': [{'title': 'Day1', 'categories': [{'measurements': [{'value': '1800', 'spread': '794', 'groupId': 'OG000'}, {'value': '6170', 'spread': '1250', 'groupId': 'OG001'}, {'value': '16100', 'spread': '8170', 'groupId': 'OG002'}, {'value': '7160', 'spread': '1960', 'groupId': 'OG003'}, {'value': '18800', 'spread': '6360', 'groupId': 'OG004'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '2060', 'spread': '708', 'groupId': 'OG000'}, {'value': '7620', 'spread': '1470', 'groupId': 'OG001'}, {'value': '28300', 'spread': '5570', 'groupId': 'OG002'}, {'value': '12100', 'spread': '4930', 'groupId': 'OG003'}, {'value': '80300', 'spread': '56300', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'Pharmacokinetics of QBW251 in plasma after multiple doses: the area under the plasma concentration-time curve from time zero to end of the dosing interval tau. In this analysis AUCtau will be reported. Samples taken on Days 1 and 14 from healthy volunteers', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 2: Maximum Concentration (Cmax) in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Cohort 1: QBW251', 'description': 'Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG001', 'title': 'Part 2 Cohort 2: QBW251', 'description': 'Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG002', 'title': 'Part 2 Cohort 3: QBW251', 'description': 'Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG003', 'title': 'Part 2 Cohort 4: QBW251', 'description': 'Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG004', 'title': 'Part 2 Cohort 5: QBW251', 'description': 'Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '541', 'spread': '338', 'groupId': 'OG000'}, {'value': '1650', 'spread': '343', 'groupId': 'OG001'}, {'value': '2790', 'spread': '1040', 'groupId': 'OG002'}, {'value': '1650', 'spread': '188', 'groupId': 'OG003'}, {'value': '3720', 'spread': '1530', 'groupId': 'OG004'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '430', 'spread': '145', 'groupId': 'OG000'}, {'value': '1500', 'spread': '442', 'groupId': 'OG001'}, {'value': '3840', 'spread': '868', 'groupId': 'OG002'}, {'value': '2190', 'spread': '769', 'groupId': 'OG003'}, {'value': '9420', 'spread': '4330', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'Pharmacokinetics of QBW251 in plasma after multiple doses: observed maximum plasma concentration following QBW251 at steady state. In this analysis Cmax will be reported using blood samples taken on Days 1 and 14 from healthy volunteers.', 'unitOfMeasure': 'ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 2: Time to Maximum Concentration (Tmax) in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Cohort 1: QBW251', 'description': 'Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG001', 'title': 'Part 2 Cohort 2: QBW251', 'description': 'Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG002', 'title': 'Part 2 Cohort 3: QBW251', 'description': 'Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG003', 'title': 'Part 2 Cohort 4: QBW251', 'description': 'Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG004', 'title': 'Part 2 Cohort 5: QBW251', 'description': 'Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '1.67', 'spread': '0.816', 'groupId': 'OG000'}, {'value': '1.17', 'spread': '0.408', 'groupId': 'OG001'}, {'value': '2.33', 'spread': '1.21', 'groupId': 'OG002'}, {'value': '2.68', 'spread': '0.813', 'groupId': 'OG003'}, {'value': '3.67', 'spread': '0.516', 'groupId': 'OG004'}]}]}, {'title': 'Day 2', 'categories': [{'measurements': [{'value': '2.17', 'spread': '1.17', 'groupId': 'OG000'}, {'value': '2.17', 'spread': '0.408', 'groupId': 'OG001'}, {'value': '2.33', 'spread': '1.03', 'groupId': 'OG002'}, {'value': '3.25', 'spread': '1.41', 'groupId': 'OG003'}, {'value': '3.80', 'spread': '0.447', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'Pharmacokinetics of QBW251 in plasma after multiple doses: time to reach the maximum concentration after administration of QBW251. In this analysis Tmax will be reported using blood samples taken on Days 1 and 14 from healthy volunteers.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 2: AUC0-t', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Cohort 1: QBW251', 'description': 'Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG001', 'title': 'Part 2 Cohort 2: QBW251', 'description': 'Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG002', 'title': 'Part 2 Cohort 3: QBW251', 'description': 'Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG003', 'title': 'Part 2 Cohort 4: QBW251', 'description': 'Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG004', 'title': 'Part 2 Cohort 5: QBW251', 'description': 'Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG005', 'title': 'Part 2 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '2060', 'spread': '708', 'groupId': 'OG000'}, {'value': '7620', 'spread': '1470', 'groupId': 'OG001'}, {'value': '28300', 'spread': '5570', 'groupId': 'OG002'}, {'value': '12100', 'spread': '4930', 'groupId': 'OG003'}, {'value': '80300', 'spread': '56300', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'Pharmacokinetics of QBW251 in plasma: area under the plasma concentration versus time curve from time zero to time of last measurable concentration. In this analysis AUC0-t will be reported using blood samples taken on Day 14 are from healthy volunteers.', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Part 2: Cav in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Cohort 1: QBW251', 'description': 'Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG001', 'title': 'Part 2 Cohort 2: QBW251', 'description': 'Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG002', 'title': 'Part 2 Cohort 3: QBW251', 'description': 'Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG003', 'title': 'Part 2 Cohort 4: QBW251', 'description': 'Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG004', 'title': 'Part 2 Cohort 5: QBW251', 'description': 'Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '85.8', 'spread': '29.5', 'groupId': 'OG000'}, {'value': '318', 'spread': '61.1', 'groupId': 'OG001'}, {'value': '1180', 'spread': '232', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient data', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient data', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'The average drug concentration in plasma during multiple dosing. In this analysis Cav will be reported using blood samples taken on Days 1 and 14 are from healthy volunteers.', 'unitOfMeasure': 'ug/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 2: CL/F in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Cohort 1: QBW251', 'description': 'Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG001', 'title': 'Part 2 Cohort 2: QBW251', 'description': 'Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG002', 'title': 'Part 2 Cohort 3: QBW251', 'description': 'Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG003', 'title': 'Part 2 Cohort 4: QBW251', 'description': 'Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG004', 'title': 'Part 2 Cohort 5: QBW251', 'description': 'Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '80.8', 'spread': '29.7', 'groupId': 'OG000'}, {'value': '54.0', 'spread': '9.40', 'groupId': 'OG001'}, {'value': '27.5', 'spread': '5.98', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient data', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient data', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'apparent systemic clearance from plasma following extravascular administration. In this analysis CL/F will be reported using blood samples taken on Day 14 from healthy volunteers.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 2: Vz/F in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Cohort 1: QBW251', 'description': 'Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG001', 'title': 'Part 2 Cohort 2: QBW251', 'description': 'Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG002', 'title': 'Part 2 Cohort 3: QBW251', 'description': 'Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG003', 'title': 'Part 2 Cohort 4: QBW251', 'description': 'Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG004', 'title': 'Part 2 Cohort 5: QBW251', 'description': 'Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '1330', 'spread': '550', 'groupId': 'OG000'}, {'value': '1120', 'spread': '395', 'groupId': 'OG001'}, {'value': '608', 'spread': '255', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient data', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient data', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'Apparent volume of distribution during the terminal elimination phase following extravascular administration. In this analysis Vz/F will be reported using blood samples taken on Day 14 from healthy volunteers.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 2: Racc in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Cohort 1: QBW251', 'description': 'Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG001', 'title': 'Part 2 Cohort 2: QBW251', 'description': 'Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG002', 'title': 'Part 2 Cohort 3: QBW251', 'description': 'Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG003', 'title': 'Part 2 Cohort 4: QBW251', 'description': 'Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG004', 'title': 'Part 2 Cohort 5: QBW251', 'description': 'Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '1.27', 'spread': '0.425', 'groupId': 'OG000'}, {'value': '1.25', 'spread': '0.199', 'groupId': 'OG001'}, {'value': '2.08', 'spread': '0.913', 'groupId': 'OG002'}, {'value': '1.66', 'spread': '0.386', 'groupId': 'OG003'}, {'value': '3.88', 'spread': '2.07', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 - 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'Accumulation ratio (Racc). In this analysis Racc will be reported using blood samples taken on Days 1 - 14 from healthy volunteers.', 'unitOfMeasure': 'Ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 2: T1/2 in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Cohort 1: QBW251', 'description': 'Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG001', 'title': 'Part 2 Cohort 2: QBW251', 'description': 'Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG002', 'title': 'Part 2 Cohort 3: QBW251', 'description': 'Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG003', 'title': 'Part 2 Cohort 4: QBW251', 'description': 'Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG004', 'title': 'Part 2 Cohort 5: QBW251', 'description': 'Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '11.3', 'spread': '1.44', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '3.80', 'groupId': 'OG001'}, {'value': '15.1', 'spread': '4.40', 'groupId': 'OG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient data', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated due to insufficient data', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'terminal elimination half-life (T1/2). In this analysis T1/2 will be reported using blood samples taken on Day 14 from healthy volunteers.', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 3: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of QBW251 in CF Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 Cohort 1: QBW251', 'description': '150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG001', 'title': 'Part 3 Cohort 2: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG002', 'title': 'Part 3 Cohort 3: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '1110', 'spread': '709', 'groupId': 'OG000'}, {'value': '7530', 'spread': '2480', 'groupId': 'OG001'}, {'value': '6020', 'spread': '2960', 'groupId': 'OG002'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '1760', 'spread': '943', 'groupId': 'OG000'}, {'value': '18900', 'spread': '6850', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'PK parameters were not calculated for Day 14 as blood samples were collected up to 2 hours post-dose.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)', 'unitOfMeasure': 'ng × hr /mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 3: Plasma Concentration at the Last Quantifiable Time Point (Clast) of QBW251 in CF Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 Cohort 1: QBW251', 'description': '150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG001', 'title': 'Part 3 Cohort 2: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG002', 'title': 'Part 3 Cohort 3: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '42.3', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '423', 'spread': '275', 'groupId': 'OG001'}, {'value': '653', 'spread': '318', 'groupId': 'OG002'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '86.4', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '1570', 'spread': '813', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'PK parameters were not calculated for Day 14 as blood samples were collected up to 2 hours post-dose', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day2', 'description': 'Blood samples were collected at timepoints prespecified in the study protocol. Tlast of QBW251 was the last time point when blood sample collected was quantifiable', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 3: Maximum Concentration (Cmax) in CF Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 Cohort 1: QBW251', 'description': '150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG001', 'title': 'Part 3 Cohort 2: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG002', 'title': 'Part 3 Cohort 3: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '419', 'spread': '316', 'groupId': 'OG000'}, {'value': '1950', 'spread': '715', 'groupId': 'OG001'}, {'value': '2380', 'spread': '1240', 'groupId': 'OG002'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '632', 'spread': '438', 'groupId': 'OG000'}, {'value': '4080', 'spread': '1780', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'PK parameters were not calculated for Day 14 as blood samples were collected up to 2 hours post-dose', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14', 'description': 'Observed maximum plasma concentration following administration of QBW251. In this analysis Cmax will be reported using blood samples taken on Day 1and day 14 from patients', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 3: Tlast in CF Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 Cohort 1: QBW251', 'description': '150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG001', 'title': 'Part 3 Cohort 2: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG002', 'title': 'Part 3 Cohort 3: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '7.99', 'spread': '0.0136', 'groupId': 'OG000'}, {'value': '7.95', 'spread': '0.149', 'groupId': 'OG001'}, {'value': '5.80', 'spread': '0.639', 'groupId': 'OG002'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '7.97', 'spread': '0.0667', 'groupId': 'OG000'}, {'value': '7.96', 'spread': '0.0554', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'PK parameters were not calculated for Day 14 as blood samples were collected up to 2 hours post-dose', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14', 'description': 'Blood samples were collected at timepoints prespecified in the study protocol. Tlast of QBW251 was the last time point when blood sample collected was quantifiable day 1 and day 14', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 3: Time to Maximum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 3 Cohort 1: QBW251', 'description': '150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG001', 'title': 'Part 3 Cohort 2: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'OG002', 'title': 'Part 3 Cohort 3: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '3.17', 'spread': '2.47', 'groupId': 'OG000'}, {'value': '3.08', 'spread': '1.68', 'groupId': 'OG001'}, {'value': '3.18', 'spread': '0.838', 'groupId': 'OG002'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '1.82', 'spread': '0.750', 'groupId': 'OG000'}, {'value': '2.39', 'spread': '0.973', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'PK parameters were not calculated for Day 14 as blood samples were collected up to 2 hours post-dose', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14', 'description': 'Pharmacokinetics of QBW251 in plasma after multiple doses: time to reach the maximum concentration after administration of QBW251. In this analysis Tmax will be reported using blood samples taken on Days 1 and 14 in patients', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 2: Ae0-t in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Cohort 1: QBW251', 'description': 'Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG001', 'title': 'Part 2 Cohort 2: QBW251', 'description': 'Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG002', 'title': 'Part 2 Cohort 3: QBW251', 'description': 'Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG003', 'title': 'Part 2 Cohort 4: QBW251', 'description': 'Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG004', 'title': 'Part 2 Cohort 5: QBW251', 'description': 'Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG005', 'title': 'Part 2 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.36', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '1.21', 'spread': '0.697', 'groupId': 'OG002'}, {'value': '0.419', 'spread': '0.271', 'groupId': 'OG003'}, {'value': '0.140', 'spread': '0.0936', 'groupId': 'OG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Not calculated', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1', 'description': 'Pharmacokinetics of QBW251 in urine: amount of drug excreted in urine from time zero until last measurable concentration. In this analysis Ae0-t will be reported using urine samples taken on Day 1 from healthy volunteers.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}, {'type': 'SECONDARY', 'title': 'Part 2: CLr in Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Part 2 Cohort 1: QBW251', 'description': 'Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG001', 'title': 'Part 2 Cohort 2: QBW251', 'description': 'Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG002', 'title': 'Part 2 Cohort 3: QBW251', 'description': 'Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG003', 'title': 'Part 2 Cohort 4: QBW251', 'description': 'Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'OG004', 'title': 'Part 2 Cohort 5: QBW251', 'description': 'Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.36', 'spread': '1.84', 'groupId': 'OG000'}, {'value': '2.20', 'spread': '1.26', 'groupId': 'OG001'}, {'value': '1.21', 'spread': '0.697', 'groupId': 'OG002'}, {'value': '0.419', 'spread': '0.271', 'groupId': 'OG003'}, {'value': '0.140', 'spread': '0.0936', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1; Day 14 was calculated as urine was only collected up to 12 hours on Day 1 thus CLr cannot be calculated.', 'description': 'Pharmacokinetics of QBW251 in urine: renal clearance following drug administration. In this analysis CLr will be reported using urine samples taken on Day 1 from healthy volunteers.', 'unitOfMeasure': 'L/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetics analysis: All subjects with at least one available valid (i.e. not flagged for exclusion) PK concentration measurement, who received study drug, and experienced no protocol deviations with relevant impact on PK data were included in the PK data analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1 Cohort 1: QBW251', 'description': 'Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'FG001', 'title': 'Part 1 Cohort 2: QBW251', 'description': 'Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'FG002', 'title': 'Part 1 Cohort 3: QBW251', 'description': 'Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'FG003', 'title': 'Part 1 Cohort 4: QBW251', 'description': 'Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'FG004', 'title': 'Part 1 Cohort 5: QBW251', 'description': 'Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'FG005', 'title': 'Part 1 Cohort 6: QBW251 (Fasting/Fed), Same Subjects', 'description': 'Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'FG006', 'title': 'Part 1 Cohort 7: QBW251', 'description': 'Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'FG007', 'title': 'Part 1 Cohort 8: QBW251', 'description': 'Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'FG008', 'title': 'Part 1 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'FG009', 'title': 'Part 2 Cohort 1: QBW251', 'description': 'Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'FG010', 'title': 'Part 2 Cohort 2: QBW251', 'description': 'Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'FG011', 'title': 'Part 2 Cohort 3: QBW251', 'description': 'Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'FG012', 'title': 'Part 2 Cohort 4: QBW251', 'description': 'Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'FG013', 'title': 'Part 2 Cohort 5: QBW251', 'description': 'Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'FG014', 'title': 'Part 2 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'FG015', 'title': 'Part 3 Cohort 1: QBW251', 'description': '150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'FG016', 'title': 'Part 3 Cohort 2: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'FG017', 'title': 'Part 3 Cohort 3: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'FG018', 'title': 'Part 3 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}], 'periods': [{'title': 'Part 1 and 2 (Healthy Volunteers)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '16'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '6'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '6'}, {'groupId': 'FG013', 'numSubjects': '6'}, {'groupId': 'FG014', 'numSubjects': '10'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '6'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '6'}, {'groupId': 'FG008', 'numSubjects': '16'}, {'groupId': 'FG009', 'numSubjects': '6'}, {'groupId': 'FG010', 'numSubjects': '6'}, {'groupId': 'FG011', 'numSubjects': '6'}, {'groupId': 'FG012', 'numSubjects': '6'}, {'groupId': 'FG013', 'numSubjects': '5'}, {'groupId': 'FG014', 'numSubjects': '8'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '2'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '1'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}]}]}, {'title': 'Part 3 (Patients)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '6'}, {'groupId': 'FG016', 'numSubjects': '12'}, {'groupId': 'FG017', 'numSubjects': '19'}, {'groupId': 'FG018', 'numSubjects': '12'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '6'}, {'groupId': 'FG016', 'numSubjects': '12'}, {'groupId': 'FG017', 'numSubjects': '19'}, {'groupId': 'FG018', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}, {'groupId': 'FG013', 'numSubjects': '0'}, {'groupId': 'FG014', 'numSubjects': '0'}, {'groupId': 'FG015', 'numSubjects': '0'}, {'groupId': 'FG016', 'numSubjects': '0'}, {'groupId': 'FG017', 'numSubjects': '0'}, {'groupId': 'FG018', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'For Cohort 6 continuing into the food effect part of the study the subjects remained on the same treatment assignment that was required during the fed state. Therefore no randomization f the subject occurred during the food effect arm. Only 5 of the 6 subjects went into the fed cohort.', 'preAssignmentDetails': 'In parts 1 and 2, participants (Healthy Volunteers) were randomized 3:1 to receive QBW251X or placebo. In part 3, participants (cystic fibrosis (CF) patients) were randomized 3:1 to receive QBW251X or placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '6', 'groupId': 'BG013'}, {'value': '10', 'groupId': 'BG014'}, {'value': '6', 'groupId': 'BG015'}, {'value': '12', 'groupId': 'BG016'}, {'value': '19', 'groupId': 'BG017'}, {'value': '12', 'groupId': 'BG018'}, {'value': '153', 'groupId': 'BG019'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1 Cohort 1: QBW251', 'description': 'Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'BG001', 'title': 'Part 1 Cohort 2: QBW251', 'description': 'Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'BG002', 'title': 'Part 1 Cohort 3: QBW251', 'description': 'Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'BG003', 'title': 'Part 1 Cohort 4: QBW251', 'description': 'Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'BG004', 'title': 'Part 1 Cohort 6: QBW251', 'description': 'Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'BG005', 'title': 'Part 1 Cohort 6: QBW251 (Fastin / Fed), Same Subjects', 'description': 'Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'BG006', 'title': 'Part 1 Cohort 7: QBW251', 'description': 'Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'BG007', 'title': 'Part 1 Cohort 8: QBW251', 'description': 'Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'BG008', 'title': 'Part 1 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).'}, {'id': 'BG009', 'title': 'Part 2 Cohort 1: QBW251', 'description': 'Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'BG010', 'title': 'Part 2 Cohort 2: QBW251', 'description': 'Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'BG011', 'title': 'Part 2 Cohort 3: QBW251', 'description': 'Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'BG012', 'title': 'Part 2 Cohort 4: QBW251', 'description': 'Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'BG013', 'title': 'Part 2 Cohort 5: QBW251', 'description': 'Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'BG014', 'title': 'Part 2 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).'}, {'id': 'BG015', 'title': 'Part 3 Cohort 1: QBW251', 'description': '150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'BG016', 'title': 'Part 3 Cohort 2: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'BG017', 'title': 'Part 3 Cohort 3: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'BG018', 'title': 'Part 3 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.'}, {'id': 'BG019', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Part 1, HV (n= 64)', 'categories': [{'measurements': [{'value': '36.3', 'spread': '8.69', 'groupId': 'BG000'}, {'value': '35', 'spread': '14.25', 'groupId': 'BG001'}, {'value': '43.5', 'spread': '3.39', 'groupId': 'BG002'}, {'value': '33.3', 'spread': '9.61', 'groupId': 'BG003'}, {'value': '44.2', 'spread': '8.23', 'groupId': 'BG004'}, {'value': '43.6', 'spread': '9.07', 'groupId': 'BG005'}, {'value': '28.2', 'spread': '9.28', 'groupId': 'BG006'}, {'value': '33.2', 'spread': '9.47', 'groupId': 'BG007'}, {'value': '30.3', 'spread': '9.18', 'groupId': 'BG008'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 1 HV', 'groupId': 'BG009'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 1 HV', 'groupId': 'BG010'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 1 HV', 'groupId': 'BG011'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 1 HV', 'groupId': 'BG012'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 1 HV', 'groupId': 'BG013'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 1 HV', 'groupId': 'BG014'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 1 HV', 'groupId': 'BG015'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 1 HV', 'groupId': 'BG016'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 1 HV', 'groupId': 'BG017'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 1 HV', 'groupId': 'BG018'}, {'value': '34.4', 'spread': '9.92', 'groupId': 'BG019'}]}]}, {'title': 'Part 2, HV (n=40)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 2 HV', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 2 HV', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 2 HV', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 2 HV', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 2 HV', 'groupId': 'BG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 2 HV', 'groupId': 'BG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 2 HV', 'groupId': 'BG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 2 HV', 'groupId': 'BG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 2 HV', 'groupId': 'BG008'}, {'value': '30.3', 'spread': '5.13', 'groupId': 'BG009'}, {'value': '30.5', 'spread': '5.89', 'groupId': 'BG010'}, {'value': '29.2', 'spread': '11.62', 'groupId': 'BG011'}, {'value': '31.7', 'spread': '13.22', 'groupId': 'BG012'}, {'value': '27.8', 'spread': '5', 'groupId': 'BG013'}, {'value': '29', 'spread': '6.22', 'groupId': 'BG014'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 2 HV', 'groupId': 'BG015'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 2 HV', 'groupId': 'BG016'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 2 HV', 'groupId': 'BG017'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 2 HV', 'groupId': 'BG018'}, {'value': '29.7', 'spread': '7.82', 'groupId': 'BG019'}]}]}, {'title': 'Part 3, CF patients (n=49)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 3 HV', 'groupId': 'BG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 3 HV', 'groupId': 'BG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 3 HV', 'groupId': 'BG002'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 3 HV', 'groupId': 'BG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 3 HV', 'groupId': 'BG004'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 3 HV', 'groupId': 'BG005'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 3 HV', 'groupId': 'BG006'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 3 HV', 'groupId': 'BG007'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 3 HV', 'groupId': 'BG008'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 3 HV', 'groupId': 'BG009'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 3 HV', 'groupId': 'BG010'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 3 HV', 'groupId': 'BG011'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 3 HV', 'groupId': 'BG012'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 3 HV', 'groupId': 'BG013'}, {'value': 'NA', 'spread': 'NA', 'comment': 'This row is for Part 3 HV', 'groupId': 'BG014'}, {'value': '39.3', 'spread': '5.47', 'groupId': 'BG015'}, {'value': '32.7', 'spread': '13.77', 'groupId': 'BG016'}, {'value': '27', 'spread': '5.44', 'groupId': 'BG017'}, {'value': '27.9', 'spread': '6.37', 'groupId': 'BG018'}, {'value': '30.1', 'spread': '9.18', 'groupId': 'BG019'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}, {'value': '0', 'groupId': 'BG011'}, {'value': '0', 'groupId': 'BG012'}, {'value': '0', 'groupId': 'BG013'}, {'value': '0', 'groupId': 'BG014'}, {'value': '1', 'groupId': 'BG015'}, {'value': '5', 'groupId': 'BG016'}, {'value': '9', 'groupId': 'BG017'}, {'value': '4', 'groupId': 'BG018'}, {'value': '19', 'groupId': 'BG019'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}, {'value': '16', 'groupId': 'BG008'}, {'value': '6', 'groupId': 'BG009'}, {'value': '6', 'groupId': 'BG010'}, {'value': '6', 'groupId': 'BG011'}, {'value': '6', 'groupId': 'BG012'}, {'value': '6', 'groupId': 'BG013'}, {'value': '10', 'groupId': 'BG014'}, {'value': '5', 'groupId': 'BG015'}, {'value': '7', 'groupId': 'BG016'}, {'value': '10', 'groupId': 'BG017'}, {'value': '8', 'groupId': 'BG018'}, {'value': '134', 'groupId': 'BG019'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 153}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2015-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2014-07-11', 'resultsFirstSubmitDate': '2016-11-23', 'studyFirstSubmitQcDate': '2014-07-14', 'lastUpdatePostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-07-18', 'studyFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part 1 and 2:Number of Participants (Healthy Volunteers) With Reported Adverse Events Receiving QBW251', 'timeFrame': 'Day 1 to Day 36', 'description': 'All adverse events (in healthy volunteers) reported.'}, {'measure': 'Part 3: Change in Lung Clearance Index (LCI) From Baseline to Day 15', 'timeFrame': 'Baseline and Day 15', 'description': 'Change in Lung Clearance Index (LCI) will be conducted according to international standards in cystic fibrosis patients. Lung clearance index (LCI) is a measure of ventilation inhomogeneity that is derived from a multiple-breath washout test, A reduction in mean change from baseline for LCI2.5 indicates improvement.'}, {'measure': 'Part 3: Number of Participants (Patients) With Reported Adverse Events Receiving QBW251', 'timeFrame': 'Day 1 to Day 56', 'description': 'All adverse events and serious adverse events (in patients) reported.'}], 'secondaryOutcomes': [{'measure': 'Part 3:Change in Forced Expiratory Volume in 1 Second (FEV1) at Day 15', 'timeFrame': 'Baseline and Day 15', 'description': 'Forced Expiratory Volume in 1 second (FEV1) will be measured via spirometer according to international standards. Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation'}, {'measure': 'Part 3: Change in Cystic Fibrosis Questionnaire-Revised Reported Outcomes', 'timeFrame': 'Baseline and Day 14', 'description': 'Change in Cystic Fibrosis Questionnaire data will be obtained from patient reported outcomes (CFQ-R PRO). Respiratory Domain, cores range from 0 to 100, with higher scores indicating better health, a change of 4 is considered clinically relevant'}, {'measure': 'Part 1: AUC0-t in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 2-5)', 'description': 'Pharmacokinetics of QBW251 in plasma: area under the plasma concentration versus time curve from time zero to time of last measurable concentration (AUC0-t). In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the AUC0-t goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered)'}, {'measure': 'Part 1: Maximum Concentration (Cmax) in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)', 'description': 'Pharmacokinetics of QBW251 in plasma: observed maximum plasma concentration following administration of QBW251. In this analysis Cmax will be reported using blood samples taken on Days 1- 5 are from healthy volunteers'}, {'measure': 'Part 1: Time to Maximum Concentration (Tmax) in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)', 'description': 'Pharmacokinetics of QBW251 in plasma: time to reach the maximum concentration after administration of QBW251. In this analysis Tmax will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In this part of the study a single dose was administered and samples were collected up to 5 days. As a result the Tmax is one value as the concentration-time curve goes to Day 5 (for some lower does QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered).'}, {'measure': 'Part 1: T1/2 in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)', 'description': 'Pharmacokinetics of QBW251 in plasma: terminal elimination half-life. In this analysis T1/2 will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the T1/2 goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered).'}, {'measure': 'Part 1: AUCinf in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)', 'description': 'Pharmacokinetics of QBW251 in plasma: area under the plasma concentration time curve from time zero to infinity. In this analysis AUCinf will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the AUCinf goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered)'}, {'measure': 'Part 1: CL/F in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)', 'description': 'Pharmacokinetics of QBW251 in plasma: apparent systemic clearance from plasma following extravascular administration. In this analysis CL/F will be reported using blood samples taken on Days 1 - 5 from healthy volunteers. In part one of the study a single dose was administered and samples were collected up to 5 days. As a result the CL/F goes from Day 1 to Day 5 (for some lower doses QBW251 concentrations were not measured up to Day 5 as the concentrations were low due to the low dose administered)'}, {'measure': 'Part 1: Vz/F in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose (i.e. Days 1 - 5)', 'description': 'Pharmacokinetics of QBW251 in plasma: apparent volume of distribution during the terminal elimination phase following extravascular administration. In this analysis Vz/F will be reported using blood samples taken on Days 1 - 5 from healthy volunteers.'}, {'measure': 'Part 2: AUCtau in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'Pharmacokinetics of QBW251 in plasma after multiple doses: the area under the plasma concentration-time curve from time zero to end of the dosing interval tau. In this analysis AUCtau will be reported. Samples taken on Days 1 and 14 from healthy volunteers'}, {'measure': 'Part 2: Maximum Concentration (Cmax) in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'Pharmacokinetics of QBW251 in plasma after multiple doses: observed maximum plasma concentration following QBW251 at steady state. In this analysis Cmax will be reported using blood samples taken on Days 1 and 14 from healthy volunteers.'}, {'measure': 'Part 2: Time to Maximum Concentration (Tmax) in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'Pharmacokinetics of QBW251 in plasma after multiple doses: time to reach the maximum concentration after administration of QBW251. In this analysis Tmax will be reported using blood samples taken on Days 1 and 14 from healthy volunteers.'}, {'measure': 'Part 2: AUC0-t', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'Pharmacokinetics of QBW251 in plasma: area under the plasma concentration versus time curve from time zero to time of last measurable concentration. In this analysis AUC0-t will be reported using blood samples taken on Day 14 are from healthy volunteers.'}, {'measure': 'Part 2: Cav in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 and 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'The average drug concentration in plasma during multiple dosing. In this analysis Cav will be reported using blood samples taken on Days 1 and 14 are from healthy volunteers.'}, {'measure': 'Part 2: CL/F in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'apparent systemic clearance from plasma following extravascular administration. In this analysis CL/F will be reported using blood samples taken on Day 14 from healthy volunteers.'}, {'measure': 'Part 2: Vz/F in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'Apparent volume of distribution during the terminal elimination phase following extravascular administration. In this analysis Vz/F will be reported using blood samples taken on Day 14 from healthy volunteers.'}, {'measure': 'Part 2: Racc in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1 - 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'Accumulation ratio (Racc). In this analysis Racc will be reported using blood samples taken on Days 1 - 14 from healthy volunteers.'}, {'measure': 'Part 2: T1/2 in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 14; ( If B ID dosing, 12 hours samples will be pre-dosed)', 'description': 'terminal elimination half-life (T1/2). In this analysis T1/2 will be reported using blood samples taken on Day 14 from healthy volunteers.'}, {'measure': 'Part 3: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of QBW251 in CF Patients', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14', 'description': 'Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)'}, {'measure': 'Part 3: Plasma Concentration at the Last Quantifiable Time Point (Clast) of QBW251 in CF Patients', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day2', 'description': 'Blood samples were collected at timepoints prespecified in the study protocol. Tlast of QBW251 was the last time point when blood sample collected was quantifiable'}, {'measure': 'Part 3: Maximum Concentration (Cmax) in CF Patients', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14', 'description': 'Observed maximum plasma concentration following administration of QBW251. In this analysis Cmax will be reported using blood samples taken on Day 1and day 14 from patients'}, {'measure': 'Part 3: Tlast in CF Patients', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14', 'description': 'Blood samples were collected at timepoints prespecified in the study protocol. Tlast of QBW251 was the last time point when blood sample collected was quantifiable day 1 and day 14'}, {'measure': 'Part 3: Time to Maximum Concentration (Tmax)', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4, 8 hr post-dose in Day 1, Day 14', 'description': 'Pharmacokinetics of QBW251 in plasma after multiple doses: time to reach the maximum concentration after administration of QBW251. In this analysis Tmax will be reported using blood samples taken on Days 1 and 14 in patients'}, {'measure': 'Part 2: Ae0-t in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1', 'description': 'Pharmacokinetics of QBW251 in urine: amount of drug excreted in urine from time zero until last measurable concentration. In this analysis Ae0-t will be reported using urine samples taken on Day 1 from healthy volunteers.'}, {'measure': 'Part 2: CLr in Healthy Volunteers', 'timeFrame': 'Pre-dose (0 hr), 0.25, 0.5, 1, 2, 3, 4 , 8 hr post-dose at Day 1; 24, 48, 72 and 96 hr post dose Day 1; Day 14 was calculated as urine was only collected up to 12 hours on Day 1 thus CLr cannot be calculated.', 'description': 'Pharmacokinetics of QBW251 in urine: renal clearance following drug administration. In this analysis CLr will be reported using urine samples taken on Day 1 from healthy volunteers.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['FEV1- Forced Expiratory volume', 'LCI - Lung Clearance Index', 'CFTR - cystic fibrosis transmembrane conductance regulator', 'cystic fibrosis', 'allergic bronchopulmonary aspergillosis'], 'conditions': ['Cystic Fibrosis']}, 'referencesModule': {'references': [{'pmid': '33293212', 'type': 'DERIVED', 'citation': 'Kazani S, Rowlands DJ, Bottoli I, Milojevic J, Alcantara J, Jones I, Kulmatycki K, Machineni S, Mostovy L, Nicholls I, Nick JA, Rowe SM, Simmonds NJ, Vegesna R, Verheijen J, Danahay H, Gosling M, Ayalavajjala PS, Salman M, Strieter R. Safety and efficacy of the cystic fibrosis transmembrane conductance regulator potentiator icenticaftor (QBW251). J Cyst Fibros. 2021 Mar;20(2):250-256. doi: 10.1016/j.jcf.2020.11.002. Epub 2020 Dec 6.'}], 'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/patientsummary/patientsummaries?patientSummaryId=127', 'label': 'A Plain Language Trial Summary is available on novartisclinicaltrials.com'}]}, 'descriptionModule': {'briefSummary': 'This study is designed to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics (proof of concept) of QBW251 in healthy subjects and cystic fibrosis patients following single and multiple doses. This first-in-human and proof of concept study will consist of 4 parts, with Parts 1 and 2 in healthy volunteers and Parts 3 and 4 in cystic fibrosis patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Key inclusion criteria (Parts 1 and 2)\n\n* Healthy female (of non-childbearing potential) and male subjects of 18 to 55 years of age (inclusive)\n* Body mass index (BMI) must be within the range of 15 to 30 kg/m2\n* Oxygen saturation (O2) at screening must be ≥ 96% on room air.\n\nKey exclusion criteria (Parts 1 and 2)\n\n* Use of any prescription drugs or herbal supplements within four (4) weeks prior to dosing or within 5 half-lives of the drug, whichever is longer\n* Over-the-counter (OTC) medication (including vitamins, dietary supplements) within two (2) weeks prior to dosing\n* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer\n* Unwilling to avoid direct sun exposure by covering exposed skin, using topical sun block and wearing sunglasses from the first dose of study drug to the end of participation in the study\n* Pregnant or nursing (lactating) women.\n\nKey inclusion criteria (Parts 3 and 4):\n\n* Male and female patients of 18 to 65 years of age (inclusive) with a confirmed diagnosis of cystic fibrosis as per the Cystic Fibrosis Foundation (CFF) consensus guidelines\n* Heterozygous with one allele represented as any CFTR mutation and the other allele must represent a class III, IV, V, VI CFTR mutation (Note: since the CFTR mutation, F508del, can be considered either a class II or III mutation, heterozygous CF patients that have one allele that contains F508del, must have the other allele contain a class III (i.e., not F508del), IV, V, or VI mutation). Patients with F508del/F508del mutation should only be included in Part 3 Cohort 3.\n* Body mass index (BMI) must be within the range of 15-35 kg/m2\n* FEV1 at Screening must be 40 to 100% predicted (inclusive) by NHANES/Hankinson standards\n* Oxygen saturation (O2) at screening must be \\> 90% on room air.\n\nKey exclusion criteria (Parts 3 and 4)\n\n* Use of herbal supplements within four (4) weeks prior to dosing or within 5 half-lives of the supplement, whichever is longer\n* Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer\n* Unwilling to avoid direct sun exposure by covering exposed skin, using topical sun block and wearing sunglasses from the first dose of study drug to the end of participation in the study\n* Pregnant or nursing (lactating) women\n* Women of child-bearing potential, UNLESS they are using highly effective contraception\n* Any changes in concomitant medications for 14 days prior to screening\n* History or clinical evidence of pancreatic injury or pancreatitis; clinical evidence of liver disease or liver injury as indicated by clinically significant abnormal liver function tests as judged by the investigator such as SGOT, SGPT, GGT, alkaline phosphatase, or serum bilirubin\n* History or presence of impaired renal function as indicated by abnormal creatinine or BUN values or abnormal urinary constituents (e.g., albuminuria)\n* History of Burkholderia cepacia respiratory tract infection (must have at least two negative cultures and no positive cultures in the past 18 months prior to screening to be eligible for enrollment)\n* Sexually active males unless they use a condom during intercourse while taking drug and for condom is required to be used also by vasectomized men in order to prevent delivery of drug via seminal fluid.\n* Patient is currently receiving (or has received within 4 weeks of baseline visit) VX-770/Ivacaftor.\n* History of lung transplant'}, 'identificationModule': {'nctId': 'NCT02190604', 'briefTitle': 'Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Randomized, Double Blind Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of Single and Multiple Ascending Doses of QBW251 in Healthy Subjects and Multiple Doses in Cystic Fibrosis Patients', 'orgStudyIdInfo': {'id': 'CQBW251X2101'}, 'secondaryIdInfos': [{'id': '2011-005085-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 1: QBW251', 'description': 'Single dose of QBW251 10 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).', 'interventionNames': ['Drug: QBW251']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 2: QBW251', 'description': 'Single dose of QBW251 25 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).', 'interventionNames': ['Drug: QBW251']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 3: QBW251', 'description': 'Single dose of QBW251 75 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).', 'interventionNames': ['Drug: QBW251']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 4: QBW251', 'description': 'Single dose of QBW251 150 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).', 'interventionNames': ['Drug: QBW251']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 5: QBW251', 'description': 'Single dose of QBW251 300 mg in healthy volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).', 'interventionNames': ['Drug: QBW251']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 6: QBW251', 'description': 'Single dose of QBW251 500 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).', 'interventionNames': ['Drug: QBW251']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 6: QBW251(fed)', 'description': 'Single dose of QBW251 500 mg (fed). single dose with food for a preliminary assessment of the effect of food on the absorption of QBW251 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).', 'interventionNames': ['Drug: QBW251']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 7: QBW251', 'description': 'Single dose of QBW251 750 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).', 'interventionNames': ['Drug: QBW251']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1 Cohort 8: QBW251', 'description': 'Single dose of QBW251 1000 mg in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).', 'interventionNames': ['Drug: QBW251']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 1 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 1 in Healthy Volunteers. Each treatment period was comprised of a baseline period (Day -1), an inpatient dosing period (Days 1 to 3), three follow-up visits (Days 4, 5, and 8), and one end-of-treatment-period evaluation performed 14 days after the dose of study drug (Day 15).', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Cohort 1: QBW251', 'description': 'Multiple doses of QBW25 150 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).', 'interventionNames': ['Drug: QBW251']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Cohort 2: QBW251', 'description': 'Multiple doses of QBW251 400 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).', 'interventionNames': ['Drug: QBW251']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Cohort 3: QBW251', 'description': 'Multiple doses of QBW251 750 mg qd in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).', 'interventionNames': ['Drug: QBW251']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Cohort 4: QBW251', 'description': 'Multiple doses of QBW251 450 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).', 'interventionNames': ['Drug: QBW251']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 Cohort 5: QBW251', 'description': 'Multiple doses of QBW251 750 mg bid in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).', 'interventionNames': ['Drug: QBW251']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 2 in Healthy Volunteers. 14-day treatment period, follow-up study visits (Days 18, 22 and 29) and one End-of-Study evaluation (Day 36).', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 Cohort 1: QBW251', 'description': '150 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.', 'interventionNames': ['Drug: QBW251']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 Cohort 2: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients having a class III, IV, V, or VI mutation on one allele and any other CFTR mutation on the other allele in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.', 'interventionNames': ['Drug: QBW251']}, {'type': 'EXPERIMENTAL', 'label': 'Part 3 Cohort 3: QBW251', 'description': '450 mg b.i.d. Multiple doses. Patients who are homozygous for the F508del mutation in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.', 'interventionNames': ['Drug: QBW251']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 3 Placebo', 'description': 'Placebo to QBW251 in all cohorts of part 3 in patients. treatment period (Day 1 to Day 14) with study visits on Days 1, 4, 7 and 14 with follow-up visits on Days 15, 28 and 42.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsule- oral dose', 'armGroupLabels': ['Part 1 Placebo', 'Part 2 Placebo', 'Part 3 Placebo']}, {'name': 'QBW251', 'type': 'DRUG', 'description': 'Capsule - oral dose', 'armGroupLabels': ['Part 1 Cohort 1: QBW251', 'Part 1 Cohort 2: QBW251', 'Part 1 Cohort 3: QBW251', 'Part 1 Cohort 4: QBW251', 'Part 1 Cohort 5: QBW251', 'Part 1 Cohort 6: QBW251', 'Part 1 Cohort 6: QBW251(fed)', 'Part 1 Cohort 7: 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