Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Hepatitis C Virus

Treatments: Drug: Velpatasvir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02002767

2013-004113-41 (EudraCT Number)

GS-US-281-1056

Details and patient eligibility

About

The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.

Enrollment: 19 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• General good health with stable chronic kidney disease in Severe Renal Impairment Group
• Screening labs within defined thresholds
• Creatinine clearance must be < 30 mL/min for Severe Renal Impairment group, and ≥ 90 mL/min for Normal Renal Function group

Key Exclusion Criteria:

• Females who are pregnant or nursing, or males who have a pregnant partner
• Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV
• History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol

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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19 participants in 2 patient groups

Participants with renal impairment

Experimental group

Description:

Participants with severe renal impairment will receive a single dose of velpatasvir.

Treatment:

Drug: Velpatasvir

Participants with normal renal function

Active Comparator group

Description:

Participants with normal renal function will receive a single dose of velpatasvir.

Treatment:

Drug: Velpatasvir