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

Hepatitis C Virus Clinical Trial

Official title:

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Renal Function and Severe Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02002767
• Other study ID #: GS-US-281-1056
• Secondary ID: 2013-004113-41
• Status: Completed
• Phase: Phase 1
• Start date: December 16, 2013
• Est. completion date: June 9, 2014

Study information

• Verified date: October 2020
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 9, 2014
• Est. primary completion date: June 9, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C Virus

Intervention

Drug:
• Velpatasvir
Velpatasvir 100 mg (2 x 50 mg tablets) administered orally

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	PK Parameter of Velpatasvir: AUCinf	AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.	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
Primary	PK Parameter of Velpatasvir: Cmax	Cmax is defined as the maximum observed plasma concentration of drug.	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	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.	First dose date plus 30 days
Secondary	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).	First dose date plus 30 days
Secondary	Percentage Protein Binding of Velpatasvir	Mean velpatasvir protein binding (percentage free and percentage bound) was determined in all participants at 2 or 3 hours post-dose. Protein binding was assessed at Tmax whenever possible or at the time point closest to Tmax for each participant.	2 or 3 hours post-dose on Day 1