To Evaluate the Effect of Ritonavir or Omeprazole on the Pharmacokinetics of Samatasvir (IDX719) in Healthy Participants (MK-1894-006)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Chronic Hepatitis C Infection

Treatments: Drug: Omeprazole; Drug: Ritonavir; Drug: Samatasvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01813552

1894-006

IDX-06A-006 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 19 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Samatasvir + Ritonavir

Experimental group

Description:

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.

Treatment:

Drug: Ritonavir

Drug: Samatasvir

Samatasvir + Omeprazole

Experimental group

Description:

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.

Treatment:

Drug: Samatasvir

Drug: Omeprazole