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

NCT ID: NCT02002767

Last Updated: 2020-11-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-16

Study Completion Date

2014-06-09

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis C Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Participants with renal impairment

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

Group Type EXPERIMENTAL

Velpatasvir

Intervention Type DRUG

Velpatasvir 100 mg (2 x 50 mg tablets) administered orally

Participants with normal renal function

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

Group Type ACTIVE_COMPARATOR

Velpatasvir

Intervention Type DRUG

Velpatasvir 100 mg (2 x 50 mg tablets) administered orally

Interventions

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Velpatasvir

Velpatasvir 100 mg (2 x 50 mg tablets) administered orally

Intervention Type DRUG

Other Intervention Names

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GS-5816

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Miami, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

Saint Paul, Minnesota, United States

Site Status

San Antonio, Texas, United States

Site Status

Christchurch, , New Zealand

Site Status

Countries

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United States New Zealand

Other Identifiers

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2013-004113-41

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-281-1056

Identifier Type: -

Identifier Source: org_study_id