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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: HCV Infection

Treatments: Drug: Voxilaprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02402452

GS-US-338-1125

2015-000341-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Normal Renal Function

Experimental group

Description:

Participants will receive a single dose of voxilaprevir on Day 1.

Treatment:

Drug: Voxilaprevir

Severe Renal Impairment

Experimental group

Description:

Participants will receive a single dose of voxilaprevir on Day 1.

Treatment:

Drug: Voxilaprevir