Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment

HCV Infection Clinical Trial

Official title:

A Phase 1 Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-9857 in Subjects With Normal Renal Function and Severe Renal Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402452
• Other study ID #: GS-US-338-1125
• Secondary ID: 2015-000341-23
• Status: Completed
• Phase: Phase 1
• Start date: May 5, 2015
• Est. completion date: September 28, 2015

Study information

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

Clinical Trial Summary

The primary objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of voxilaprevir (formerly GS-9857) in participants with severe renal impairment and matched healthy control participants.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 28, 2015
• Est. primary completion date: September 28, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Key Inclusion Criteria:

• All individuals:

• Screening laboratory values within defined thresholds for group

• Use of two effective contraception methods if female of childbearing potential or sexually active male

• For individuals with severe renal impairment:

• Stable chronic kidney disease

• Creatinine clearance (CLcr) < 30 mL/min

Key Exclusion Criteria:

• All individuals:

• Pregnant or nursing female or male with pregnant female partner

• Hepatitis B virus, hepatitis C virus (HCV) or HIV infection

• History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

• For individuals with severe renal impairment:

• Anticipated to require dialysis within 90 days of study dosing

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Related Conditions & MeSH terms

• HCV Infection
• Hepatitis C
• Renal Insufficiency

Intervention

Drug:
• Voxilaprevir
100 mg tablet administered orally

Locations

Country	Name	City	State
Germany	APEX GmbH	München
New Zealand	Christchurch Clinical Studies Trust Ltd	Christchurch
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Texas Liver Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Germany,  New Zealand, 

References & Publications (1)

Lawitz E, Marbury T, Kirby BJ, Au NT, Mathias A, Stamm LM, Wei H, Sajwani K, Klein G, Gane E, Robson R. The effect of renal or hepatic impairment on the pharmacokinetics of GS-9857, a pangenotypic HCV NS3/4A protease inhibitor. The International Liver Con

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast	AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration. Data presented are unadjusted geometric means and confidence intervals.	0 (predose = 5 min) and 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose
Primary	PK Parameter of Voxilaprevir: AUCinf	AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time. Data presented are unadjusted geometric means and confidence intervals.	0 (pre-dose = 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose
Primary	PK Parameter of Voxilaprevir: Cmax	Cmax is defined as the maximum observed plasma concentration of drug. Data presented are unadjusted geometric means and confidence intervals.	0 (pre-dose = 5 minutes), 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, and 120 hours postdose
Secondary	Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAE) and Laboratory Abnormalities	The percentage of participants experiencing any TEAE or treatment-emergent laboratory abnormality was summarized.	First dose date to Day 31