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

Phase 1CompletedNCT02002767

Gilead Sciences19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis C Virus

Interventions

VelpatasvirDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 79 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

Unnamed facility

Miami, Florida, United States

Unnamed facility

Orlando, Florida, United States

Unnamed facility

Saint Paul, Minnesota, United States

Unnamed facility

San Antonio, Texas, United States

Unnamed facility

Outcomes

Primary Outcomes

Pharmacokinetic (PK) Parameter of Velpatasvir: AUClast

AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.

Time frame: Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1

PK Parameter of Velpatasvir: AUCinf

AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.

Time frame: Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1

PK Parameter of Velpatasvir: Cmax

Cmax is defined as the maximum observed plasma concentration of drug.

Time frame: Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1

Secondary Outcomes

Percentage of Participants Experiencing Treatment-Emergent Adverse Events

Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.

Time frame: First dose date plus 30 days

Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug and within 30 days after last study drug administration. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening).

Time frame: First dose date plus 30 days

Data from ClinicalTrials.gov

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