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

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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)

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

Trial contacts and locations

5

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Data sourced from clinicaltrials.gov

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