Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-02-28

Brief Summary

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The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and tolerability of single-dose administration of IDX719 in participants with normal hepatic function and participants with varying degrees of hepatic impairment.

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Detailed Description

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Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1: Child-Pugh Class A

Participants with mild hepatic impairment (Child-Pugh Class A score = 5-6) will receive a single dose of 100 mg IDX719 by mouth on Day 1.

Group Type EXPERIMENTAL

IDX719

Intervention Type DRUG

IDX719 supplied as 50 mg tablets.

Cohort 2: Child-Pugh Class B

Participants with moderate hepatic impairment (Child-Pugh Class B score = 7-9) will receive a single dose of 100 mg IDX719 by mouth on Day 1.

Group Type EXPERIMENTAL

IDX719

Intervention Type DRUG

IDX719 supplied as 50 mg tablets.

Cohort 3: Child-Pugh Class C

Participants with severe hepatic impairment (Child-Pugh Class C score = 10-15) will receive a single dose of 100 mg IDX719 by mouth on Day 1.

Group Type EXPERIMENTAL

IDX719

Intervention Type DRUG

IDX719 supplied as 50 mg tablets.

Interventions

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IDX719

IDX719 supplied as 50 mg tablets.

Intervention Type DRUG

Other Intervention Names

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Samatasvir

Eligibility Criteria

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Inclusion Criteria

* Read and sign the written informed consent form (ICF) after the nature of the study has been fully explained.
* All subjects of childbearing potential must have agreed 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.
* Male subjects have agreed not to donate sperm from Day -1 through 90 days after the last dose of study drug.