Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT02599792
Status:
COMPLETED
Last Update Posted:
2016-05-02
First Post:
2015-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Volunteer Solid Oral Dose and Multiple Ascending Dose Evaluation of CTP-656
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-29', 'studyFirstSubmitDate': '2015-11-05', 'studyFirstSubmitQcDate': '2015-11-06', 'lastUpdatePostDateStruct': {'date': '2016-05-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-11-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '7 days', 'description': 'adverse events categorized by body system and MedDRA term'}, {'measure': 'Measure exposure of test articles using area under the concentration time curve (AUC)', 'timeFrame': '96 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Safety and Pharmacokinetics'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Two-part study to assess CTP-656 dosed as a solid oral dosage form versus Kalydeco and multiple-ascending doses of CTP-656 dosed for 7 days.', 'detailedDescription': 'This two-part study will assess in healthy male and female subjects a solid oral dose formulation of CTP-656 vs. Kalydeco® and the safety, tolerability and pharmacokinetic profiles of escalating CTP-656 solid oral doses following 7 days of dosing. In Part B, three doses of CTP-656 ranging from 75 mg up to 300 mg per day will be studied.'}, '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': 'NCT02599792', 'briefTitle': 'Healthy Volunteer Solid Oral Dose and Multiple Ascending Dose Evaluation of CTP-656', 'organization': {'class': 'INDUSTRY', 'fullName': 'Concert Pharmaceuticals'}, 'officialTitle': 'A Two-Part Phase 1 Healthy Volunteer Study: A Crossover Comparison of CTP-656 Solid Dose Formulation vs. Kalydeco® and a Double-Blind, Placebo-Controlled, Ascending Multiple Dose Evaluation of CTP-656', 'orgStudyIdInfo': {'id': 'CP656.1002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CTP-656, 150 mg', 'description': 'Single Oral Dose', 'interventionNames': ['Drug: CTP-656']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Kalydeco, 150 mg', 'description': 'Single oral dose', 'interventionNames': ['Drug: Kalydeco']}, {'type': 'EXPERIMENTAL', 'label': 'CTP-656, 75 mg or matching placebo', 'description': 'Subjects will be administered 75 mg CTP-656 for 7 days.', 'interventionNames': ['Drug: CTP-656', 'Drug: Placebo for CTP-656']}, {'type': 'EXPERIMENTAL', 'label': 'CTP-656, 150 mg or matching placebo', 'description': 'Subjects will be administered 150 mg CTP-656 for 7 days.', 'interventionNames': ['Drug: CTP-656', 'Drug: Placebo for CTP-656']}, {'type': 'EXPERIMENTAL', 'label': 'CTP-656, high dose or matching placebo', 'description': 'Subjects will be administered up to 300 mg CTP-656 for 7 days.', 'interventionNames': ['Drug: CTP-656', 'Drug: Placebo for CTP-656']}], 'interventions': [{'name': 'CTP-656', 'type': 'DRUG', 'armGroupLabels': ['CTP-656, 150 mg', 'CTP-656, 150 mg or matching placebo', 'CTP-656, 75 mg or matching placebo', 'CTP-656, high dose or matching placebo']}, {'name': 'Placebo for CTP-656', 'type': 'DRUG', 'armGroupLabels': ['CTP-656, 150 mg or matching placebo', 'CTP-656, 75 mg or matching placebo', 'CTP-656, high dose or matching placebo']}, {'name': 'Kalydeco', 'type': 'DRUG', 'armGroupLabels': ['Kalydeco, 150 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', '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'}}}}