Study to Evaluate Drug-Drug Interaction Between IDX719 and Simeprevir in Healthy Participants (MK-1894-004)
- Registration Number
- NCT01813513
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (PK) of IDX719 in healthy participants. Part 1 will evaluate potential PK interactions between IDX719 and simeprevir. Part 2 will evaluate the effect of food on the PK of IDX719 in combination with simeprevir. Part 3 will evaluate the impact of high- versus low-fat meals on the PK of IDX719.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- Has no clinically significant abnormalities on medical history, physical examination, or 12-lead electrocardiogram (ECG)
- Agrees to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of study drug
- Agrees to avoid nicotine-containing products from 3 months prior to Screening and for the duration of the study
Exclusion Criteria
- Is positive for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) antibodies
- Is pregnant or breastfeeding
- Has previously received either IDX719 or simeprevir
- Has participated in another clinical drug study within 30 days of Screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A: IDX719 then IDX719/Simeprevir Simeprevir Healthy participants take IDX719 150 mg once daily (QD) on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14. Group B: Simeprevir then IDX719/Simeprevir IDX719 Healthy participants take simeprevir 150 mg QD on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14. Group B: Simeprevir then IDX719/Simeprevir Simeprevir Healthy participants take simeprevir 150 mg QD on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14. Group C: IDX719 IDX719 Healthy participants take IDX719 150 mg QD on Days 1-14. Group D: IDX719/Simeprevir Simeprevir Participants from Groups A and B will be asked to return for Group D. Participants take IDX719 and simeprevir QD on Days 1-7 to determine the impact of food on single-dose (on Day 1) and steady state (Day 7) PK. Group E: High-Fat then Low-Fat PK IDX719 Participants from Group C will return to determine the PK of IDX719 after high-fat (Day 1) and low-fat (Day 7) meals (Days 2-6 are drug-free washout). Group F: Low-Fat then High-Fat PK IDX719 Participants from Group C will return to determine the PK of IDX719 after low-fat (Day 1) and high-fat (Day 7) meals (Days 2-6 are drug-free washout). Group A: IDX719 then IDX719/Simeprevir IDX719 Healthy participants take IDX719 150 mg once daily (QD) on Days 1-7 and IDX719 150 mg QD + simeprevir 150 mg QD on Days 8-14. Group D: IDX719/Simeprevir IDX719 Participants from Groups A and B will be asked to return for Group D. Participants take IDX719 and simeprevir QD on Days 1-7 to determine the impact of food on single-dose (on Day 1) and steady state (Day 7) PK.
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) Up to 30 days Area under the plasma concentration-time curve (AUC) at steady-state over dosing interval (AUCss) Up to 30 days AUC from time zero to infinity Up to 30 days Trough plasma concentration (Ctrough) Up to 30 days
- Secondary Outcome Measures
Name Time Method Percentage of participants experiencing serious adverse events (SAEs) Up to 30 days Percentage of participants experiencing adverse events (AEs) Up to 30 days Percentage of participants experiencing Grade 1-4 laboratory abnormalities Up to 30 days