Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT04742218
Status:
COMPLETED
Last Update Posted:
2021-08-09
First Post:
2021-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study to Assess the Food Effect of K-877 in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000603947', 'term': 'K-877 compound'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-05', 'studyFirstSubmitDate': '2021-01-29', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': 'Baseline to Day 6'}], 'primaryOutcomes': [{'measure': 'Cmax of K-877', 'timeFrame': 'pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4', 'description': 'Observed maximum plasma concentration (Cmax)'}, {'measure': 'AUC0-t of K-877', 'timeFrame': 'pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4', 'description': 'Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration (AUC0-t)'}, {'measure': 'AUC0-inf of K-877', 'timeFrame': 'pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4', 'description': 'Area under the plasma concentration versus time curve from time 0 extrapolated to infinity (AUC0-inf)'}], 'secondaryOutcomes': [{'measure': 'Tmax of K-877', 'timeFrame': 'pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4', 'description': 'Time to reach the observed maximum (peak) plasma concentration (Tmax)'}, {'measure': 'MRT0-t of K-877', 'timeFrame': 'pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4', 'description': 'Mean residence time from time 0 to the time of the last quantifiable concentration (MRT0-t)'}, {'measure': 'MRT0-inf of K-877', 'timeFrame': 'pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4', 'description': 'Mean residence time from time 0 extrapolated to infinity (MRT0-inf)'}, {'measure': 't1/2 of K-877', 'timeFrame': 'pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4', 'description': 'Terminal elimination half-life (t1/2)'}, {'measure': 'Kel of K-877', 'timeFrame': 'pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4', 'description': 'Terminal elimination rate constant (Kel)'}, {'measure': 'CL/F of K-877', 'timeFrame': 'pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4', 'description': 'Apparent oral clearance (CL/F)'}, {'measure': 'Vd/F of K-877', 'timeFrame': 'pre-dose (within 1 hour before dosing and at pre-meal in case of fed condition) and at 0.25, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, and 24 hours after dosing on Days 1 and 4', 'description': 'Apparent volume of distribution (Vd/F)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'Study is to assess the effects of food on the Pharmacokinetics(PK) of single-dose administration of K-877 in healthy adult volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject provides written informed consent before any study-specific evaluation is performed;\n* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at screening;\n* Subject has a BMI of 18 to 30 kg/m2, inclusive, at screening\n* Subject meets all inclusion criteria outlined in the clinical study protocol\n\nExclusion Criteria:\n\n* Subject is a woman who is pregnant or breastfeeding;\n* Subject has clinically significant abnormalities in the screening or check-in assessments;\n* Subject has received an investigational drug within 30 days or 5 half-lives (whichever is longer) before the first dose of study drug\n* Subject does not meet any other exclusion criteria outlined in clinical study protocol.'}, 'identificationModule': {'nctId': 'NCT04742218', 'briefTitle': 'Study to Assess the Food Effect of K-877 in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kowa Research Institute, Inc.'}, 'officialTitle': 'A Randomized, Open Label, Two-sequence, Two-period Crossover Study to Assess the Food Effect on the Pharmacokinetics of Single-Dose Administration of the To-Be-Marketed Formulation of K-877 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'K-877-110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fasted-Fed', 'description': 'Single dose of K-877 administered in a fasted condition on Day 1 (Treatment Period 1) and postprandially on Day 4 (Treatment Period 2)', 'interventionNames': ['Drug: K-877']}, {'type': 'EXPERIMENTAL', 'label': 'Fed-Fasted', 'description': 'Single dose of K-877 administered postprandially on Day 1 (Treatment Period 1) and in a fasted condition on Day 4 (Treatment Period 2)', 'interventionNames': ['Drug: K-877']}], 'interventions': [{'name': 'K-877', 'type': 'DRUG', 'description': 'K-877 Tablet', 'armGroupLabels': ['Fasted-Fed', 'Fed-Fasted']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'PPD Development, LP', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Shona Pendse, MD, MMSc', 'role': 'STUDY_CHAIR', 'affiliation': 'Kowa Research Institute, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kowa Research Institute, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}