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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Hepatitis C, Chronic

Treatments: Drug: IDX719

Study type: Interventional

Funder types: Industry

Identifiers

NCT01919125

IDX-06A -008

1894-008

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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.

Exclusion criteria

• Pregnant or breastfeeding.
• Other clinically significant medical conditions or laboratory abnormalities

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 3 patient groups

Cohort 1: Child-Pugh Class A

Experimental group

Description:

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.

Treatment:

Drug: IDX719

Cohort 2: Child-Pugh Class B

Experimental group

Description:

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.

Treatment:

Drug: IDX719

Cohort 3: Child-Pugh Class C

Experimental group

Description:

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.

Treatment:

Drug: IDX719