To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006)
Phase 1
Completed
- Conditions
- Chronic Hepatitis C Infection
- Interventions
- Registration Number
- NCT01813552
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
This study is designed to evaluate the potential for an effect of Ritonavir (Norvir®) or omeprazole (Prilosec®) on the pharmacokinetics of samatasvir and to assess the safety and tolerability of the study drugs when administered alone and in combination in healthy participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
- Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained.
- All participants of childbearing potential must agree 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 the study drug.
Exclusion Criteria
- Pregnant or breastfeeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Samatasvir + Ritonavir Ritonavir Days 1, 9 and 13: Healthy Volunteers will take samatasvir in the mornings under fed or fasted conditions with water. Days 5-16: Healthy Volunteers will take ritonavir in the mornings under fasted or fed conditions with water. Samatasvir + Omeprazole Omeprazole Days 1, 9 and 13: Healthy Volunteers will take samatasvir in the mornings under fasted conditions with water or Coke. Days 5-16: Healthy Volunteers will take omeprazole in the mornings under fasted conditions with water or Coke. Samatasvir + Ritonavir Samatasvir Days 1, 9 and 13: Healthy Volunteers will take samatasvir in the mornings under fed or fasted conditions with water. Days 5-16: Healthy Volunteers will take ritonavir in the mornings under fasted or fed conditions with water. Samatasvir + Omeprazole Samatasvir Days 1, 9 and 13: Healthy Volunteers will take samatasvir in the mornings under fasted conditions with water or Coke. Days 5-16: Healthy Volunteers will take omeprazole in the mornings under fasted conditions with water or Coke.
- Primary Outcome Measures
Name Time Method Pharmacokinetic parameter: Maximum observed drug concentration (Cmax) 0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours Pharmacokinetic parameter: Area under the concentration-time curve (AUC) from time zero to last measurable concentration 0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours Pharmacokinetic parameter: AUC from time zero to infinity 0 hour (pre-dose) and post-dose at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, and 96 hours
- Secondary Outcome Measures
Name Time Method Percentage of participants who experienced at least one serious adverse event Up to 17 days Percentage of participants who experienced at least one adverse event Up to 17 days Percentage of participants who experienced at least one Grade 1 - 4 laboratory abnormality Up to 17 days