Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT01508156
Status:
COMPLETED
Last Update Posted:
2015-04-27
First Post:
2012-01-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000597389', 'term': 'samatasvir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-24', 'studyFirstSubmitDate': '2012-01-09', 'studyFirstSubmitQcDate': '2012-01-09', 'lastUpdatePostDateStruct': {'date': '2015-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants experiencing an adverse event (AE)', 'timeFrame': 'Up to 14 days'}, {'measure': 'Percentage of participants experiencing serious AEs (SAEs)', 'timeFrame': 'Up to 14 days'}, {'measure': 'Change in HCV ribonucleic acid (RNA)', 'timeFrame': 'Baseline and Day 10'}, {'measure': 'Maximum plasma drug concentration (Cmax)', 'timeFrame': 'Pre-dose Day 1 to Day 13'}, {'measure': 'Time to maximum plasma drug concentration (Tmax)', 'timeFrame': 'Pre-dose Day 1 to Day 13'}, {'measure': 'Area under the plasma drug concentration-time curve (AUC) from time zero to time of last measurable concentration (AUC0-t)', 'timeFrame': 'Pre-dose Day 1 to Day 13'}, {'measure': 'AUC from time zero to time 24 hours (AUC0-24h)', 'timeFrame': 'Pre-dose Day 1 to Day 1'}, {'measure': 'AUC from time zero to time infinity (AUC0-~)', 'timeFrame': 'Pre-dose Day 1 to Day 13'}, {'measure': 'Pre-dose trough plasma drug concentration (Ctrough)', 'timeFrame': 'Pre-dose Day 1'}, {'measure': 'Observed terminal plasma drug concentration half-life (t1/2)', 'timeFrame': 'Pre-dose Day 1 to Day 13'}, {'measure': 'Apparent oral total plasma drug clearance (CL/F) as Dose/AUC0-~ (single dose) or Dose/AUC0-t (multiple doses)', 'timeFrame': 'Pre-dose Day 1 to Day 13'}, {'measure': 'Apparent oral total volume of distribution (Vz/F)', 'timeFrame': 'Pre-dose Day 1 to Day 13'}, {'measure': 'Amount excreted in urine in each collection interval (Au)', 'timeFrame': 'Pre-dose Day 1 to Day 14'}, {'measure': 'Cumulative urine excretion (Au0-t)', 'timeFrame': 'Pre-dose Day 1 to Day 14'}, {'measure': 'Percentage of dose excreted in urine (% Dose excr)', 'timeFrame': 'Pre-dose Day 1 to Day 14'}, {'measure': 'Renal clearance (CLr)', 'timeFrame': 'Pre-dose Day 1 to Day 14'}, {'measure': 'Percentage of participants experiencing dose-limiting toxicity', 'timeFrame': 'Up to 8 days'}, {'measure': 'Percentage of participants experiencing graded laboratory abnormalities', 'timeFrame': 'Up to 14 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hepatitis C', 'HCV', 'treatment-naive'], 'conditions': ['Hepatitis C, Chronic']}, 'referencesModule': {'references': [{'pmid': '24434503', 'type': 'RESULT', 'citation': "Vince B, Hill JM, Lawitz EJ, O'Riordan W, Webster LR, Gruener DM, Mofsen RS, Murillo A, Donovan E, Chen J, McCarville JF, Sullivan-Bolyai JZ, Mayers D, Zhou XJ. A randomized, double-blind, multiple-dose study of the pan-genotypic NS5A inhibitor samatasvir in patients infected with hepatitis C virus genotype 1, 2, 3 or 4. J Hepatol. 2014 May;60(5):920-7. doi: 10.1016/j.jhep.2014.01.003. Epub 2014 Jan 14."}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to test the safety and tolerability of different doses of IDX719 to find the best dose for future studies. The study will also assess the pharmacokinetics of IDX719. No formal hypotheses will be tested.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Participants\n* Is in good general health.\n* Agrees to use double-barrier method of birth control for at least 90 days after the last dose of study drugs.\n* HCV Participants\n* Has documented GT1, GT2, or GT3 chronic HCV infection.\n\nExclusion Criteria:\n\n* All Participants\n* Is pregnant or breastfeeding.\n\nHCV Participants\n\n* Has received prior HCV treatment.\n* Is co-infected with hepatitis B virus (HBV) and/or human immunodeficiency virus (HIV).'}, 'identificationModule': {'nctId': 'NCT01508156', 'briefTitle': 'Study of Hepatitis C Virus (HCV) Nonstructural Protein 5a (NS5A) Inhibitor IDX719 in Healthy and HCV-Infected Participants (MK-1894-001)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase I/IIa Study Assessing Single and Multiple Doses of HCV NS5A Inhibitor IDX719 in Healthy and HCV-Infected Subjects', 'orgStudyIdInfo': {'id': '1894-001'}, 'secondaryIdInfos': [{'id': 'IDX-06A-001', 'type': 'OTHER', 'domain': 'Idenix Pharmaceuticals, Inc'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A: Healthy Participants', 'description': 'Healthy participants take IDX719 (5 mg - 100 mg) or matching placebo by mouth as either 1 single dose or as 7 daily doses.', 'interventionNames': ['Drug: IDX719', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group B: HCV Participants', 'description': 'Treatment-naive participants infected with HCV genotype (GT) 1, GT2, or GT3 take IDX719 (1 mg - 100 mg) or matching placebo as either 1 single dose or as 7 daily doses.', 'interventionNames': ['Drug: IDX719', 'Drug: Placebo']}], 'interventions': [{'name': 'IDX719', 'type': 'DRUG', 'description': 'IDX719 liquid suspension (1 - 100 mg) taken by mouth.', 'armGroupLabels': ['Group A: Healthy Participants', 'Group B: HCV Participants']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo liquid suspension matching IDX719 taken by mouth.', 'armGroupLabels': ['Group A: Healthy Participants', 'Group B: HCV Participants']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}