A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics of IDX719 in Subjects With Normal and Impaired Hepatic Function
Overview
- Phase
- Phase 1
- Intervention
- IDX719
- Conditions
- Hepatitis C, Chronic
- Sponsor
- Merck Sharp & Dohme LLC
- Enrollment
- 36
- Primary Endpoint
- Maximum plasma concentration (Cmax)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: IDX719
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.
Intervention: IDX719
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.
Intervention: IDX719
Outcomes
Primary Outcomes
Maximum plasma concentration (Cmax)
Time Frame: Up to 6 days
Time to maximum plasma concentration (Tmax)
Time Frame: Up to 6 days
Area under the curve (AUC) from time zero to last measurable concentration (AUC0-last)
Time Frame: Up to 6 days
AUC from time zero to infinity (AUC0-~)
Time Frame: Up to 6 days
AUC from time zero to 24 hours (AUC0-24h)
Time Frame: Up to 6 days
Plasma concentration 24 hours after dosing (C24h)
Time Frame: Up to 6 days
Apparent terminal elimination rate constant
Time Frame: Up to 6 days
Observed terminal half-life (T1/2)
Time Frame: Up to 6 days
Secondary Outcomes
- Percentage of participants experiencing an adverse event (AE)(Up to 6 days)
- Percentage of participants experiencing serious adverse events (SAEs)(Up to 6 days)
- Percentage of participants experiencing Grade 1-4 laboratory abnormalities(Up to 6 days)