A Drug-Drug Interaction Study Evaluating the Combination of IDX320 and IDX184 in Healthy Participants (MK-6844-002)
Phase 1
Completed
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT01157104
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
To participate in the study, participants must meet the following requirements:
- 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.
- Must be a non-smoker.
- Must agree to use an acceptable double-barrier method of birth control.
- Must provide written informed consent after the study has been fully explained.
Exclusion Criteria
Participants are not eligible if they meet any of the following:
- Pregnant or breastfeeding.
- History of clinically significant diseases, as determined by the investigator.
- Safety laboratory abnormalities at screening which are clinically significant.
- Positive screening test for hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV).
- 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.
- Current abuse of alcohol or illicit drugs, or history of alcohol or illicit drug abuse within the preceding two years.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description IDX320 + PBO → IDX320 + IDX184 IDX320 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 IDX320 + PBO → IDX320 + IDX184 IDX184 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 IDX320 + PBO → IDX320 + IDX184 IDX184 placebo 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 IDX184 + PBO → IDX184 + IDX320 IDX184 100 mg IDX184 and IDX320 matching PBO for 7 days; followed by 100 mg IDX184 and 400 mg IDX320 for 7 days IDX184 + PBO → IDX184 + IDX320 IDX320 placebo 100 mg IDX184 and IDX320 matching PBO for 7 days; followed by 100 mg IDX184 and 400 mg IDX320 for 7 days IDX320 PBO + IDX184 PBO IDX184 placebo IDX320 matching PBO + IDX184 matching PBO for 14 days IDX320 PBO + IDX184 PBO IDX320 placebo IDX320 matching PBO + IDX184 matching PBO for 14 days IDX184 + PBO → IDX184 + IDX320 IDX320 100 mg IDX184 and IDX320 matching PBO for 7 days; followed by 100 mg IDX184 and 400 mg IDX320 for 7 days
- Primary Outcome Measures
Name Time Method Area under the curve at steady state (AUCss) of plasma IDX320 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 AUCss of plasma IDX184 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 AUCss of plasma 2'-methylguanosine (2'-MeG) 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 Maximum observed concentration (Cmax) of plasma IDX320 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 Cmax of plasma IDX184 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 Cmax of plasma 2'-MeG 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 Trough concentration (Ctrough) of plasma IDX320 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 Ctrough of plasma 2"-MeG 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 Ctrough of plasma IDX184 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
- Secondary Outcome Measures
Name Time Method Number of participants with an adverse event (AE) Up to Day 19 Number of participants who discontinued treatment due to an AE Up to Day 14