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To Evaluate the Effect of Rit...

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

Last Updated: 2016-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Hepatitis C Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Samatasvir + 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.

Group Type EXPERIMENTAL

Samatasvir

Intervention Type DRUG

Samatasvir 150 mg oral tablets (50mg x 3), single dose

Ritonavir

Intervention Type DRUG

100 mg oral tablets, once daily

Samatasvir + 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.

Group Type EXPERIMENTAL

Samatasvir

Intervention Type DRUG

Samatasvir 150 mg oral tablets (50mg x 3), single dose

Omeprazole

Intervention Type DRUG

40 mg delayed-release oral capsules, once daily

Interventions

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Samatasvir

Samatasvir 150 mg oral tablets (50mg x 3), single dose

Intervention Type DRUG

Omeprazole

40 mg delayed-release oral capsules, once daily

Intervention Type DRUG

Ritonavir

100 mg oral tablets, once daily

Intervention Type DRUG

Eligibility Criteria

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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.