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

Merck Sharp & Dohme (MSD) logo

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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