Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of voxilaprevir (formerly GS-9857) in participants with severe renal impairment and matched healthy control participants.

Official Title
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A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9857 in Subjects With Normal Renal Function and Severe Renal Impairment

Conditions
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HCV Infection

Intervention / Treatment
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* Drug: Voxilaprevir


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: All individuals: Screening laboratory values within defined thresholds for group Use of two effective contraception methods if female of childbearing potential or sexually active male For individuals with severe renal impairment: Stable chronic kidney disease Creatinine clearance (CLcr) < 30 mL/min Key Exclusion Criteria: All individuals: Pregnant or nursing female or male with pregnant female partner Hepatitis B virus, hepatitis C virus (HCV) or HIV infection History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol For individuals with severe renal impairment: Anticipated to require dialysis within 90 days of study dosing Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal Renal Function<br>Participants will receive a single dose of voxilaprevir on Day 1. | Drug: Voxilaprevir<br>* 100 mg tablet administered orally<br>* Other names: GS-9857;|
| Experimental: Severe Renal Impairment<br>Participants will receive a single dose of voxilaprevir on Day 1. | Drug: Voxilaprevir<br>* 100 mg tablet administered orally<br>* Other names: GS-9857;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast | AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. Data presented are unadjusted geometric means and confidence intervals. | 0 (predose ≤ 5 min) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose | 
| PK Parameter of Voxilaprevir: AUCinf | AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time. Data presented are unadjusted geometric means and confidence intervals. | 0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose | 
| PK Parameter of Voxilaprevir: Cmax | Cmax is defined as the maximum observed plasma concentration of drug. Data presented are unadjusted geometric means and confidence intervals. | 0 (pre-dose ≤ 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAE) and Laboratory Abnormalities | The percentage of participants experiencing any TEAE or treatment-emergent laboratory abnormality was summarized. | First dose date to Day 31 |