Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-27 @ 4:20 AM
Study NCT ID:
NCT01473056
Status:
COMPLETED
Last Update Posted:
2011-11-21
First Post:
2011-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C578010', 'term': 'JTK-853'}]}}, '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': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'completionDateStruct': {'date': '2011-09', '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': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects with adverse events', 'timeFrame': '1 week'}, {'measure': 'Maximum concentration (Cmax) of JTK-853 and metabolite M2', 'timeFrame': '1 week'}, {'measure': 'Time to reach maximum concentration (tmax) for JTK-853 and metabolite M2', 'timeFrame': '1 week'}, {'measure': 'Area under the concentration-time curve during the dosing interval (AUCtau) for JTK-853 and Metabolite M2', 'timeFrame': '1 week'}, {'measure': 'Trough concentration during multiple dosing prior to next dose (Ctrough) for JTK-853 and metabolite M2', 'timeFrame': '1 week'}, {'measure': 'Viral load change from baseline to end of treatment', 'timeFrame': '48 weeks'}, {'measure': 'Genotypic resistance assessment and viral load change from baseline over time', 'timeFrame': '48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis C', 'JTK-853'], 'conditions': ['Hepatitis C Virus Infection, Response to Therapy of']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the safety, tolerability, pharmacokinetics and anti-viral activity of JTK-853 in hepatitis C virus genotype 1 infected subjects based on reduction in viral load (HCV RNA level) from baseline to end of treatment, followed by genotypic resistance monitoring for up to one year after study drug treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males and females infected with chronic hepatitis C virus (HCV) infection and genotype 1a or 1b\n2. Subjects with a viral load (HCV RNA level) of ≥50,000 IU/mL\n3. Subjects with a body mass index (BMI) of 18.0-36.0 kg/m2 (inclusive)\n\nExclusion Criteria:\n\n1. Subjects should not have previously received a direct acting anti-HCV agent\n2. Subjects should not previously have received pegylated interferon/ribavirin for a duration of more than two weeks'}, 'identificationModule': {'nctId': 'NCT01473056', 'briefTitle': 'Study to Assess Safety,Tolerability,Pharmacokinetics & Antiviral Activity of JTK-853 in Hepatitis C Virus Genotype 1 Infected Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Akros Pharma Inc.'}, 'officialTitle': 'Phase I,Randomized,Double-blind,Placebo-controlled,Multiple Dose Study Evaluating Safety,Tolerability,Pharmacokinetics and Antiviral Activity of JTK-853 in HCV Genotype 1 Infected Subjects,Followed by a Genotypic Resistance Monitoring Study', 'orgStudyIdInfo': {'id': 'AK853-U-09-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dose 1 JTK-853', 'interventionNames': ['Drug: JTK-853']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 2 JTK-853', 'interventionNames': ['Drug: Dose 2 JTK-853']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 3 JTK-853', 'interventionNames': ['Drug: Dose 3 JTK-853']}, {'type': 'EXPERIMENTAL', 'label': 'Dose 4 JTK-853', 'interventionNames': ['Drug: Dose 4 JTK-853']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'JTK-853', 'type': 'DRUG', 'description': 'Tablets, twice a day for 3 days', 'armGroupLabels': ['Dose 1 JTK-853']}, {'name': 'Dose 2 JTK-853', 'type': 'DRUG', 'description': 'Tablets, twice a day for 3 days', 'armGroupLabels': ['Dose 2 JTK-853']}, {'name': 'Dose 3 JTK-853', 'type': 'DRUG', 'description': 'Tablets, three times a day for 3 days', 'armGroupLabels': ['Dose 3 JTK-853']}, {'name': 'Dose 4 JTK-853', 'type': 'DRUG', 'description': 'Tablets, twice a day for 3 days', 'armGroupLabels': ['Dose 4 JTK-853']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets, twice a day or three times a day for 3 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00927', 'city': 'San Juan', 'country': 'Puerto Rico', 'facility': 'Fundacion de Investigacion de Diego', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], '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'}}}}