Ignite Creation Date:
2025-12-26 @ 5:19 PM
Ignite Modification Date:
2025-12-29 @ 8:00 AM
Study NCT ID:
NCT06181006
Status:
COMPLETED
Last Update Posted:
2025-01-14
First Post:
2023-12-13
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate Pirtobrutinib (LOXO-305) in Healthy Adult Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723100', 'term': 'pirtobrutinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov@lilly.com', 'phone': '800-545-5979', 'title': 'Chief Medical Officer', 'organization': 'Eli Lilly and Company'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Upto 46 days', 'description': 'All enrolled participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1: 300 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 300 mg administered orally on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 2: 600 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 3: 800 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Cohort 4: 900 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Petechiae', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: 300 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 300 mg administered orally on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: 600 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3: 800 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4: 900 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to 46 days', 'description': 'TEAE is defined as an adverse event (AE) which starts on or after the first administration of study drug. A serious adverse event is defined as any AE occurring at any dose that results in any of the following outcomes: death; a life-threatening adverse drug experience; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacity; a congenital anomaly/birth defect; an important medical event that may require medical or surgical intervention to prevent any of the above outcomes.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: 300 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 300 mg administered orally on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: 600 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3: 800 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4: 900 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '84100', 'spread': '27.2', 'groupId': 'OG000'}, {'value': '135000', 'spread': '81.8', 'groupId': 'OG001'}, {'value': '200000', 'spread': '22.6', 'groupId': 'OG002'}, {'value': '225000', 'spread': '22.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24 hours post-dose)', 'description': 'PK: AUC0-24 of Pirtobrutinib.', 'unitOfMeasure': 'hour*nanogram per milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed.'}, {'type': 'SECONDARY', 'title': 'PK: Area Under the Concentration Versus Time Curve From Hour Zero to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: 300 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 300 mg administered orally on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: 600 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3: 800 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4: 900 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '143000', 'spread': '29.8', 'groupId': 'OG000'}, {'value': '259000', 'spread': '101', 'groupId': 'OG001'}, {'value': '379000', 'spread': '16.9', 'groupId': 'OG002'}, {'value': '490000', 'spread': '26.8', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: AUC0-t of Pirtobrutinib.', 'unitOfMeasure': 'hour*nanogram per milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed.'}, {'type': 'SECONDARY', 'title': 'PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Pirtobrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: 300 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 300 mg administered orally on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: 600 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3: 800 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4: 900 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '144000', 'spread': '30.1', 'groupId': 'OG000'}, {'value': '260000', 'spread': '100', 'groupId': 'OG001'}, {'value': '382000', 'spread': '16.9', 'groupId': 'OG002'}, {'value': '492000', 'spread': '26.9', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: AUC0-inf of Pirtobrutinib.', 'unitOfMeasure': 'hour*nanogram per milliliter (h*ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed.'}, {'type': 'SECONDARY', 'title': 'PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: 300 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 300 mg administered orally on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: 600 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3: 800 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4: 900 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.869', 'spread': '39.9', 'groupId': 'OG000'}, {'value': '0.504', 'spread': '61.2', 'groupId': 'OG001'}, {'value': '0.474', 'spread': '113', 'groupId': 'OG002'}, {'value': '0.458', 'spread': '48.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: %AUCextrap of pirtobrutinib.', 'unitOfMeasure': 'percentage of AUCextrap', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed.'}, {'type': 'SECONDARY', 'title': 'PK: Maximum Observed Plasma Concentration (Cmax) of Pirtobrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: 300 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 300 mg administered orally on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: 600 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3: 800 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4: 900 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '6600', 'spread': '28.7', 'groupId': 'OG000'}, {'value': '9050', 'spread': '65.9', 'groupId': 'OG001'}, {'value': '13700', 'spread': '32.8', 'groupId': 'OG002'}, {'value': '13000', 'spread': '27.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: Cmax of Pirtobrutinib.', 'unitOfMeasure': 'nanogram per milliliter (ng/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed.'}, {'type': 'SECONDARY', 'title': 'PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: 300 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 300 mg administered orally on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: 600 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3: 800 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4: 900 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.25', 'groupId': 'OG000', 'lowerLimit': '1.50', 'upperLimit': '7.00'}, {'value': '2.75', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '4.00'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '2.50', 'upperLimit': '7.00'}, {'value': '4.01', 'groupId': 'OG003', 'lowerLimit': '2.50', 'upperLimit': '9.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: Tmax of Pirtobrutinib.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed.'}, {'type': 'SECONDARY', 'title': 'PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: 300 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 300 mg administered orally on Day 1.'}], 'classes': [{'title': 'Subject 1', 'categories': [{'measurements': [{'value': '0.0367', 'groupId': 'OG000'}]}]}, {'title': 'Subject 2', 'categories': [{'measurements': [{'value': '0.0423', 'groupId': 'OG000'}]}]}, {'title': 'Subject 3', 'categories': [{'measurements': [{'value': '0.0242', 'groupId': 'OG000'}]}]}, {'title': 'Subject 4', 'categories': [{'measurements': [{'value': '0.0477', 'groupId': 'OG000'}]}]}, {'title': 'Subject 5', 'categories': [{'measurements': [{'value': '0.0285', 'groupId': 'OG000'}]}]}, {'title': 'Subject 6', 'categories': [{'measurements': [{'value': '0.0469', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: λZ of Pirtobrutinib.', 'unitOfMeasure': '1/hour (1/h)', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose 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'groupId': 'OG000'}]}]}, {'title': 'Subject 6', 'categories': [{'measurements': [{'value': '0.0368', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: λZ of Pirtobrutinib.', 'unitOfMeasure': '1/hour (1/h)', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed.'}, {'type': 'SECONDARY', 'title': 'PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 3: 800 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.'}], 'classes': [{'title': 'Subject 1', 'categories': [{'measurements': [{'value': '0.0279', 'groupId': 'OG000'}]}]}, {'title': 'Subject 2', 'categories': [{'measurements': [{'value': '0.0263', 'groupId': 'OG000'}]}]}, {'title': 'Subject 3', 'categories': [{'measurements': [{'value': '0.0339', 'groupId': 'OG000'}]}]}, {'title': 'Subject 4', 'categories': [{'measurements': [{'value': '0.0339', 'groupId': 'OG000'}]}]}, {'title': 'Subject 5', 'categories': [{'measurements': [{'value': '0.0295', 'groupId': 'OG000'}]}]}, {'title': 'Subject 6', 'categories': [{'measurements': [{'value': '0.0410', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: λZ of Pirtobrutinib.', 'unitOfMeasure': '1/hour (1/h)', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed.'}, {'type': 'SECONDARY', 'title': 'PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 4)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 4: 900 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.'}], 'classes': [{'title': 'Subject 1', 'categories': [{'measurements': [{'value': '0.0291', 'groupId': 'OG000'}]}]}, {'title': 'Subject 2', 'categories': [{'measurements': [{'value': '0.0367', 'groupId': 'OG000'}]}]}, {'title': 'Subject 3', 'categories': [{'measurements': [{'value': '0.0330', 'groupId': 'OG000'}]}]}, {'title': 'Subject 4', 'categories': [{'measurements': [{'value': '0.0313', 'groupId': 'OG000'}]}]}, {'title': 'Subject 5', 'categories': [{'measurements': [{'value': '0.0320', 'groupId': 'OG000'}]}]}, {'title': 'Subject 6', 'categories': [{'measurements': [{'value': '0.0396', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: λZ of Pirtobrutinib.', 'unitOfMeasure': '1/hour (1/h)', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed.'}, {'type': 'SECONDARY', 'title': 'PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: 300 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 300 mg administered orally on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: 600 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3: 800 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4: 900 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.08', 'spread': '30.1', 'groupId': 'OG000'}, {'value': '2.31', 'spread': '100', 'groupId': 'OG001'}, {'value': '2.10', 'spread': '16.9', 'groupId': 'OG002'}, {'value': '1.83', 'spread': '26.9', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: CL/F of Pirtobrutinib.', 'unitOfMeasure': 'liter per hour (L/h)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed.'}, {'type': 'SECONDARY', 'title': 'PK: Apparent Volume of Distribution at Terminal Phase (Vz/F) of Pirtobrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: 300 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 300 mg administered orally on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: 600 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3: 800 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4: 900 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '57.0', 'spread': '23.5', 'groupId': 'OG000'}, {'value': '67.1', 'spread': '96.2', 'groupId': 'OG001'}, {'value': '66.1', 'spread': '26.4', 'groupId': 'OG002'}, {'value': '54.7', 'spread': '23.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: Vz/F of Pirtobrutinib.', 'unitOfMeasure': 'Liter (L)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed.'}, {'type': 'SECONDARY', 'title': 'PK: Apparent Plasma Terminal Elimination Half-life (t1/2) of Pirtobrutinib', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1: 300 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 300 mg administered orally on Day 1.'}, {'id': 'OG001', 'title': 'Cohort 2: 600 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.'}, {'id': 'OG002', 'title': 'Cohort 3: 800 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.'}, {'id': 'OG003', 'title': 'Cohort 4: 900 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.0', 'spread': '28.4', 'groupId': 'OG000'}, {'value': '20.2', 'spread': '7.71', 'groupId': 'OG001'}, {'value': '21.9', 'spread': '16.3', 'groupId': 'OG002'}, {'value': '20.7', 'spread': '11.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: t1/2 of Pirtobrutinib.', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received a dose of Pirtobrutinib, had at least 1 quantifiable PK concentration of Pirtobrutinib and had at least 1 PK parameter computed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: 300 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 300 milligram (mg) administered orally on Day 1.'}, {'id': 'FG001', 'title': 'Cohort 2: 600 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.'}, {'id': 'FG002', 'title': 'Cohort 3: 800 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.'}, {'id': 'FG003', 'title': 'Cohort 4: 900 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1: 300 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 300 mg administered orally on Day 1.'}, {'id': 'BG001', 'title': 'Cohort 2: 600 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.'}, {'id': 'BG002', 'title': 'Cohort 3: 800 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.'}, {'id': 'BG003', 'title': 'Cohort 4: 900 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '41.8', 'spread': '11.79', 'groupId': 'BG000'}, {'value': '36.2', 'spread': '9.15', 'groupId': 'BG001'}, {'value': '33.2', 'spread': '10.85', 'groupId': 'BG002'}, {'value': '35.3', 'spread': '5.47', 'groupId': 'BG003'}, {'value': '36.6', 'spread': '9.55', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All enrolled participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-04', 'size': 8728477, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-10-10T08:50', 'hasProtocol': True}, {'date': '2020-11-16', 'size': 1209635, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-10-04T09:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-10', 'studyFirstSubmitDate': '2023-12-13', 'resultsFirstSubmitDate': '2024-11-19', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-10', 'studyFirstPostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs)', 'timeFrame': 'Baseline up to 46 days', 'description': 'TEAE is defined as an adverse event (AE) which starts on or after the first administration of study drug. A serious adverse event is defined as any AE occurring at any dose that results in any of the following outcomes: death; a life-threatening adverse drug experience; inpatient hospitalization or prolongation of existing hospitalization; a persistent or significant disability/incapacity; a congenital anomaly/birth defect; an important medical event that may require medical or surgical intervention to prevent any of the above outcomes.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 24 Hours Post-dose (AUC0-24) of Pirtobrutinib', 'timeFrame': 'Day 1 (predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24 hours post-dose)', 'description': 'PK: AUC0-24 of Pirtobrutinib.'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve From Hour Zero to the Last Measurable Concentration (AUC0-t) of Pirtobrutinib', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: AUC0-t of Pirtobrutinib.'}, {'measure': 'PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) of Pirtobrutinib', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: AUC0-inf of Pirtobrutinib.'}, {'measure': 'PK: Percentage Extrapolation for AUC0-inf (%AUCextrap) of Pirtobrutinib', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: %AUCextrap of pirtobrutinib.'}, {'measure': 'PK: Maximum Observed Plasma Concentration (Cmax) of Pirtobrutinib', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: Cmax of Pirtobrutinib.'}, {'measure': 'PK: Time to Maximum Observed Plasma Concentration (Tmax) of Pirtobrutinib', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: Tmax of Pirtobrutinib.'}, {'measure': 'PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 1)', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: λZ of Pirtobrutinib.'}, {'measure': 'PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 2)', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: λZ of Pirtobrutinib.'}, {'measure': 'PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 3)', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: λZ of Pirtobrutinib.'}, {'measure': 'PK: Apparent Terminal Elimination Rate Constant (λZ) of Pirtobrutinib (Cohort 4)', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: λZ of Pirtobrutinib.'}, {'measure': 'PK: Apparent Systemic Clearance (CL/F) of Pirtobrutinib', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: CL/F of Pirtobrutinib.'}, {'measure': 'PK: Apparent Volume of Distribution at Terminal Phase (Vz/F) of Pirtobrutinib', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: Vz/F of Pirtobrutinib.'}, {'measure': 'PK: Apparent Plasma Terminal Elimination Half-life (t1/2) of Pirtobrutinib', 'timeFrame': 'Day 1 (Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 7, 9, 12, 24, 48, 72, 96, 120, 144, and 168 hours post-dose)', 'description': 'PK: t1/2 of Pirtobrutinib.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to assess the safety and tolerability of pirtobrutinib and to look at the amount of the study drug, pirtobrutinib, that gets into the blood stream and how long it takes the body to get rid of it when given in healthy adult participants. For each participant, the total duration of the study will be 46 days, including screening.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive\n* Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator\n* Female participants of non-childbearing potential and male participants who follow standard contraceptive methods\n* Must have comply with all study procedures, including the 8-night stay at the Clinical Research Unit (CRU) and follow-up phone call\n\nExclusion Criteria:\n\nHistory or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor\n\n* Positive serologic test for hepatitis B surface antigen (HBsAg), hepatitis B virus immunoglobulin M (HBV IgM) core antibody, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antibody at Screening\n* Positive polymerase chain reaction (PCR) test for COVID-19 at Screening or Check-in (Day -1)\n* Known ongoing alcohol and/or drug abuse within 2 years prior to Screening\n* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)\n* Have previously completed or withdrawn from any other study investigating Pirtobrutinib (LOXO-305) and have previously received the investigational product'}, 'identificationModule': {'nctId': 'NCT06181006', 'briefTitle': 'A Study to Evaluate Pirtobrutinib (LOXO-305) in Healthy Adult Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eli Lilly and Company'}, 'officialTitle': 'A Phase I, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LOXO-305 in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': 'LOXO-BTK-20017'}, 'secondaryIdInfos': [{'id': 'J2N-OX-JZNS', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: 300 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 300 milligram (mg) administered orally on Day 1.', 'interventionNames': ['Drug: Pirtobrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: 600 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 600 mg administered orally on Day 1.', 'interventionNames': ['Drug: Pirtobrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3: 800 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 800 mg administered orally on Day 1.', 'interventionNames': ['Drug: Pirtobrutinib']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4: 900 mg Pirtobrutinib', 'description': 'Participants received a single dose of Pirtobrutinib 900 mg administered orally on Day 1.', 'interventionNames': ['Drug: Pirtobrutinib']}], 'interventions': [{'name': 'Pirtobrutinib', 'type': 'DRUG', 'otherNames': ['LOXO-305', 'LY3527727'], 'description': 'Administered orally.', 'armGroupLabels': ['Cohort 1: 300 mg Pirtobrutinib', 'Cohort 2: 600 mg Pirtobrutinib', 'Cohort 3: 800 mg Pirtobrutinib', 'Cohort 4: 900 mg Pirtobrutinib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Covance Clinical Research Unit', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}], 'overallOfficials': [{'name': 'Renee Ward, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Loxo Oncology, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Loxo Oncology, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}