To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006)
NCT01813552 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2016-01-22
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.
Conditions
- Chronic Hepatitis C Infection
Interventions
- DRUG
-
Samatasvir
Samatasvir 150 mg oral tablets (50mg x 3), single dose
- DRUG
-
Omeprazole
40 mg delayed-release oral capsules, once daily
- DRUG
-
Ritonavir
100 mg oral tablets, once daily
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Medical Director · Merck Sharp & Dohme LLC
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-02-28
- Primary Completion
- 2013-03-31
- Completion
- 2013-03-31
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