Ignite Creation Date:
2025-12-25 @ 4:24 AM
Ignite Modification Date:
2026-03-02 @ 8:03 PM
Study NCT ID:
NCT03316820
Status:
COMPLETED
Last Update Posted:
2019-05-03
First Post:
2017-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability Study of K0706 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-02', 'studyFirstSubmitDate': '2017-10-17', 'studyFirstSubmitQcDate': '2017-10-17', 'lastUpdatePostDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observed peak plasma concentration', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'Adverse event', 'timeFrame': '26 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This is single-center, single-dose, randomized, open-label, four-period, four sequence crossover study to evaluate the relative bioavailability of K0706 24 mg tablet formulation relative to 24 mg capsule formulation under fasted conditions and to evaluate the food-effect for tablet formulation in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willingness to provide written, informed consent for participation in the study in the compliance with the protocol requirements\n2. Adult males or females aged between 18 and 55 years\n3. Medically healthy on the basis of medical history and physical examination\n4. Woman of childbearing potential must practice an acceptable method of birth control\n\nExclusion Criteria:\n\n1. History of any major surgical or medical conditions within 4 weeks prior to dosing\n2. History of blood transfusion and / or plasmapheresis within 4 weeks prior to dosing\n3. Inability to swallow oral medication and / or difficulty to find peripheral access to veins or inability to undergo venipuncture\n4. Any malignancy within the past 3 years (except for non-melanoma skin cancer or cervical cancer in situ)'}, 'identificationModule': {'nctId': 'NCT03316820', 'briefTitle': 'Bioavailability Study of K0706 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sun Pharma Advanced Research Company Limited'}, 'officialTitle': 'A Randomized, Open Label, Four Period, Four Sequence, Single Dose, Crossover Study to Evaluate Relative Bioavailability of K0706 24 mg Tablet Formulation Relative to 24 mg Capsule Formulation Under Fasted Conditions and to Evaluate the Food Effect for Tablet Formulation in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CLR_17_07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'K0706 tablet', 'interventionNames': ['Drug: K0706']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'K0706 tablet', 'interventionNames': ['Drug: K0706']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'description': 'K0706 tablet', 'interventionNames': ['Drug: K0706']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D', 'description': 'K0706 capsule', 'interventionNames': ['Drug: K0706']}], 'interventions': [{'name': 'K0706', 'type': 'DRUG', 'description': 'Study treatment with water after an overnight fast', 'armGroupLabels': ['Treatment A', 'Treatment B', 'Treatment C', 'Treatment D']}, {'name': 'K0706', 'type': 'DRUG', 'description': 'Study treatment with water after food', 'armGroupLabels': ['Treatment A', 'Treatment B', 'Treatment C', 'Treatment D']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89121', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'SPARC Site 1', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Pharma Advanced Research Company Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}