Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-30 @ 8:30 AM
Study NCT ID:
NCT01157104
Status:
COMPLETED
Last Update Posted:
2016-01-22
First Post:
2010-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002)
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': 'C574703', 'term': 'IDX320'}, {'id': 'C557801', 'term': 'IDX184'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-20', 'studyFirstSubmitDate': '2010-07-02', 'studyFirstSubmitQcDate': '2010-07-02', 'lastUpdatePostDateStruct': {'date': '2016-01-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the curve at steady state (AUCss) of plasma IDX320', 'timeFrame': 'Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose'}, {'measure': 'AUCss of plasma IDX184', 'timeFrame': 'Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose'}, {'measure': "AUCss of plasma 2'-methylguanosine (2'-MeG)", 'timeFrame': 'Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose'}, {'measure': 'Maximum observed concentration (Cmax) of plasma IDX320', 'timeFrame': 'Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose'}, {'measure': 'Cmax of plasma IDX184', 'timeFrame': 'Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose'}, {'measure': "Cmax of plasma 2'-MeG", 'timeFrame': 'Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose'}, {'measure': 'Trough concentration (Ctrough) of plasma IDX320', 'timeFrame': 'Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose'}, {'measure': 'Ctrough of plasma IDX184', 'timeFrame': 'Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose'}, {'measure': 'Ctrough of plasma 2"-MeG', 'timeFrame': 'Days 1-7 pre-dose; Day 7: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20 hrs postdose; Days 8-14 pre-dose; Day 14: 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hrs postdose'}], 'secondaryOutcomes': [{'measure': 'Number of participants with an adverse event (AE)', 'timeFrame': 'Up to Day 19'}, {'measure': 'Number of participants who discontinued treatment due to an AE', 'timeFrame': 'Up to Day 14'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HCV', 'Hepatitis C'], 'conditions': ['Chronic Hepatitis C']}, 'descriptionModule': {'briefSummary': 'This study is designed to evaluate the potential for a pharmacokinetic (PK) drug-drug interaction between IDX320 and IDX184 and to assess the safety and tolerability when the two drugs are administered in combination in healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nTo participate in the study, participants must meet the following requirements:\n\n1. Must be a healthy male or female between 19 and 65 years of age with body mass index (BMI) between 18 and 35 kg/m2.\n2. Must be a non-smoker.\n3. Must agree to use an acceptable double-barrier method of birth control.\n4. Must provide written informed consent after the study has been fully explained.\n\nExclusion Criteria:\n\nParticipants are not eligible if they meet any of the following:\n\n1. Pregnant or breastfeeding.\n2. History of clinically significant diseases, as determined by the investigator.\n3. Safety laboratory abnormalities at screening which are clinically significant.\n4. Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).\n5. Use of chronic prescription medications within 3 months, acute prescription medications within 14 days, or systemic over-the-counter (OTC) medications within 7 days of the starting the study.\n6. Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.'}, 'identificationModule': {'nctId': 'NCT01157104', 'briefTitle': 'A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Phase I, Double-Blind, Multiple-Dose Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between IDX320 and IDX184 in Healthy Subjects', 'orgStudyIdInfo': {'id': '6844-002'}, 'secondaryIdInfos': [{'id': 'IDX-07A-002', 'type': 'OTHER', 'domain': 'Idenix'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IDX320 + PBO → IDX320 + IDX184', 'description': '400 mg IDX320 and IDX184 matching placebo (PBO) once daily for 7 days; followed by 400 mg IDX320 and 100 mg IDX184 once daily for 7 days', 'interventionNames': ['Drug: IDX320', 'Drug: IDX184', 'Drug: IDX184 placebo']}, {'type': 'EXPERIMENTAL', 'label': 'IDX184 + PBO → IDX184 + IDX320', 'description': '100 mg IDX184 and IDX320 matching PBO for 7 days; followed by 100 mg IDX184 and 400 mg IDX320 for 7 days', 'interventionNames': ['Drug: IDX320', 'Drug: IDX184', 'Drug: IDX320 placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'IDX320 PBO + IDX184 PBO', 'description': 'IDX320 matching PBO + IDX184 matching PBO for 14 days', 'interventionNames': ['Drug: IDX184 placebo', 'Drug: IDX320 placebo']}], 'interventions': [{'name': 'IDX320', 'type': 'DRUG', 'description': 'IDX320 400 mg in tablets (8x50 mg) administered orally once daily', 'armGroupLabels': ['IDX184 + PBO → IDX184 + IDX320', 'IDX320 + PBO → IDX320 + IDX184']}, {'name': 'IDX184', 'type': 'DRUG', 'description': 'IDX184 100 mg in capsules (2x50 mg) administered orally once daily', 'armGroupLabels': ['IDX184 + PBO → IDX184 + IDX320', 'IDX320 + PBO → IDX320 + IDX184']}, {'name': 'IDX184 placebo', 'type': 'DRUG', 'description': 'IDX184 matching placebo in capsules administered orally once daily', 'armGroupLabels': ['IDX320 + PBO → IDX320 + IDX184', 'IDX320 PBO + IDX184 PBO']}, {'name': 'IDX320 placebo', 'type': 'DRUG', 'description': 'IDX320 matching placebo in tablets administered orally once daily', 'armGroupLabels': ['IDX184 + PBO → IDX184 + IDX320', 'IDX320 PBO + IDX184 PBO']}]}, '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'}}}}