Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)
- Registration Number
- NCT01919125
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cohort 1: Child-Pugh Class A IDX719 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. Cohort 2: Child-Pugh Class B IDX719 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. Cohort 3: Child-Pugh Class C IDX719 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.
- Primary Outcome Measures
Name Time Method Observed terminal half-life (T1/2) Up to 6 days Maximum plasma concentration (Cmax) Up to 6 days Time to maximum plasma concentration (Tmax) Up to 6 days Area under the curve (AUC) from time zero to last measurable concentration (AUC0-last) Up to 6 days AUC from time zero to infinity (AUC0-~) Up to 6 days AUC from time zero to 24 hours (AUC0-24h) Up to 6 days Plasma concentration 24 hours after dosing (C24h) Up to 6 days Apparent terminal elimination rate constant Up to 6 days
- Secondary Outcome Measures
Name Time Method Percentage of participants experiencing serious adverse events (SAEs) Up to 6 days Percentage of participants experiencing an adverse event (AE) Up to 6 days Percentage of participants experiencing Grade 1-4 laboratory abnormalities Up to 6 days