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

Study Overview
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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.

Official Title
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A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of IDX719 in Subjects With Normal and Impaired Hepatic Function

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Drug: IDX719


Participation Criteria
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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. Exclusion Criteria: Pregnant or breastfeeding. Other clinically significant medical conditions or laboratory abnormalities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Child-Pugh Class A<br>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. | Drug: IDX719<br>* IDX719 supplied as 50 mg tablets.<br>* Other names: Samatasvir;|
| Experimental: Cohort 2: Child-Pugh Class B<br>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. | Drug: IDX719<br>* IDX719 supplied as 50 mg tablets.<br>* Other names: Samatasvir;|
| Experimental: Cohort 3: Child-Pugh Class C<br>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. | Drug: IDX719<br>* IDX719 supplied as 50 mg tablets.<br>* Other names: Samatasvir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Observed terminal half-life (T1/2) |  | Up to 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hepatitis C, Hepatitis C virus, HCV