Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-03-05 @ 4:11 AM
Study NCT ID:
NCT02392702
Status:
COMPLETED
Last Update Posted:
2015-09-23
First Post:
2015-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate Safety, Tolerability and PK of C-10355 and C-10358 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C545203', 'term': 'ivacaftor'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-22', 'studyFirstSubmitDate': '2015-03-05', 'studyFirstSubmitQcDate': '2015-03-13', 'lastUpdatePostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '24 hours', 'description': 'adverse events categorized by body system and MedDRA term'}, {'measure': 'Pharmacokinetic Profile', 'timeFrame': '96 hours', 'description': 'Measure exposure of test articles using area under the concentration time curve (AUC), maximum concentration (Cmax), half life (T 1/2)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Subjects', 'Safety/Efficacy Study', 'Randomized', 'Open Label'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This two-part study will assess, in healthy volunteers, under both fasted and fed conditions, and in a sequential manner, the safety, tolerability and pharmacokinetics (PK) profile of single doses of C-10355 and C-10358 and single ascending doses of the selected compound compared to a single dose of Kalydeco®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy adults between 18 and 50 years of age, inclusive\n* Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive, at screening\n\nExclusion Criteria:\n\n* History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal (including nephrolithiasis), hepatic, including history of Gilbert's syndrome or gastrointestinal (GI) conditions\n* PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcF interval \\> 450 msec obtained at screening visit or prior to the first dose of study drug\n* Liver function tests greater than the upper limit of normal.\n* Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody at screening\n* Urinalysis positive for greater than trace blood, protein or glucose\n* A positive screen for alcohol, drugs of abuse, or tobacco use.\n* Inability to comply with food and beverage restrictions during study participation.\n* Donation or blood collection or acute loss of blood prior to screening."}, 'identificationModule': {'nctId': 'NCT02392702', 'briefTitle': 'Study to Evaluate Safety, Tolerability and PK of C-10355 and C-10358 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Concert Pharmaceuticals'}, 'officialTitle': 'A Two-Part Open-Label, Randomized, Sequential, Crossover, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of C-10355 and C-10358 in Healthy Volunteers, With a PK Comparison to Kalydeco®', 'orgStudyIdInfo': {'id': 'CP656.1001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'C-10355, 25 mg', 'description': 'single oral dose.', 'interventionNames': ['Drug: C-10355']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C-10358, 25 mg', 'description': 'single oral dose.', 'interventionNames': ['Drug: C-10358']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C-10355 or C-10358, 75 mg', 'description': 'single oral dose.', 'interventionNames': ['Drug: C-10355', 'Drug: C-10358']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C-10355 or C-10358, 150 mg', 'description': 'single oral dose.', 'interventionNames': ['Drug: C-10355', 'Drug: C-10358']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Kalydeco, 150 mg', 'description': 'single oral dose.', 'interventionNames': ['Drug: Kalydeco']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'C-10355 or C-10358, 300 mg', 'description': 'single oral dose.', 'interventionNames': ['Drug: C-10355', 'Drug: C-10358']}], 'interventions': [{'name': 'C-10355', 'type': 'DRUG', 'armGroupLabels': ['C-10355 or C-10358, 150 mg', 'C-10355 or C-10358, 300 mg', 'C-10355 or C-10358, 75 mg', 'C-10355, 25 mg']}, {'name': 'C-10358', 'type': 'DRUG', 'armGroupLabels': ['C-10355 or C-10358, 150 mg', 'C-10355 or C-10358, 300 mg', 'C-10355 or C-10358, 75 mg', 'C-10358, 25 mg']}, {'name': 'Kalydeco', 'type': 'DRUG', 'armGroupLabels': ['Kalydeco, 150 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'CMAX', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Lana Pilja', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Concert Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Concert Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}