Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-02-28 @ 2:49 AM
Study NCT ID:
NCT01473069
Status:
TERMINATED
Last Update Posted:
2011-11-21
First Post:
2011-11-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Week Study Evaluating Safety, Tolerability and Pharmacokinetics of Multiple Doses of JTK-853 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C578010', 'term': 'JTK-853'}, {'id': 'D007654', 'term': 'Ketoconazole'}], 'ancestors': [{'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 41}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-17', 'studyFirstSubmitDate': '2011-11-09', 'studyFirstSubmitQcDate': '2011-11-14', 'lastUpdatePostDateStruct': {'date': '2011-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with adverse events', 'timeFrame': '3 weeks'}], 'secondaryOutcomes': [{'measure': 'Maximum concentration (Cmax) of JTK-853 and metabolite M2', 'timeFrame': '3 weeks'}, {'measure': 'Time to reach peak or maximum concentration (tmax) for JTK-853 and metabolite M2', 'timeFrame': '3 weeks'}, {'measure': 'Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2', 'timeFrame': '3 weeks'}, {'measure': 'Elimination half-life associated with the terminal slope (λz) of a semilogarithmic concentration-time curve (t1/2) for JTK-853 and metabolite M2', 'timeFrame': '3 weeks'}, {'measure': 'Maximum concentration (Cmax) of JTK-853 and metabolite M2 after Ketoconazole administration', 'timeFrame': '3 weeks'}, {'measure': 'Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and metabolite M2 after ketoconazole administration', 'timeFrame': '3 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['JTK-853', 'Healthy subjects'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the safety, tolerability and pharmacokinetics of sequential ascending doses of JTK-853 administered for 14 days in healthy subjects and also to determine the effect of a single dose of ketoconazole on the steady-state pharmacokinetic profile of JTK-853 and its metabolite M2 (one cohort only).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Body Mass Index (BMI) ≥18.0 kg/m2 and ≤30.0 kg/m2\n2. Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit\n3. Female subjects must be either surgically sterile or postmenopausal\n\nExclusion Criteria:\n\n1. History or presence of cardiac disease, including a family history of long-QT syndrome or unexplained sudden death\n2. Have used any prescription medication, herbal product, or over-the-counter (OTC) medication (except acetaminophen) within four weeks prior to Day -1'}, 'identificationModule': {'nctId': 'NCT01473069', 'briefTitle': 'Two Week Study Evaluating Safety, Tolerability and Pharmacokinetics of Multiple Doses of JTK-853 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akros Pharma Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating the Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of JTK-853 Administered for Two Weeks in Healthy Subjects', 'orgStudyIdInfo': {'id': 'AK853-U-10-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1 JTK-853, 400 mg ketoconazole', 'interventionNames': ['Drug: JTK-853, ketoconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2 JTK-853', 'interventionNames': ['Drug: JTK-853 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3 JTK-853', 'interventionNames': ['Drug: JTK-853 or Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 4 JTK-853', 'interventionNames': ['Drug: JTK-853 or Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: JTK-853 or Placebo']}], 'interventions': [{'name': 'JTK-853, ketoconazole', 'type': 'DRUG', 'description': 'JTK-853 Tablets or Placebo, twice a day for 14 days, JTK-853 and ketoconazole Tablets, 1 each on Day 15', 'armGroupLabels': ['Dose 1 JTK-853, 400 mg ketoconazole']}, {'name': 'JTK-853 or Placebo', 'type': 'DRUG', 'description': 'JTK-853 Tablets or Placebo, twice a day for 14 days', 'armGroupLabels': ['Dose 2 JTK-853', 'Dose 3 JTK-853', 'Dose 4 JTK-853', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'PPD Phase I Clinic', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Shoji Hoshino, D.V.M', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Akros Pharma Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akros Pharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}