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

Phase 1

Completed

• Conditions: HCV Infection
• Interventions: Drug: Voxilaprevir

• Registration Number: NCT02402452
• Lead Sponsor: Gilead Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-03-25
• Study First Posted: 2015-03-30
• Study Start: 2015-05-05
• Primary Completion: 2015-09-28
• Study Completion: 2015-09-28
• Status Verified: 2020-03
• Results First Submitted: 2020-03-04
• Results First Submitted QC: 2020-03-04
• Last Update Submitted: 2020-03-04
• Results First Posted: 2020-03-20
• Last Update Posted: 2020-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Renal Function	Voxilaprevir	Participants will receive a single dose of voxilaprevir on Day 1.
Severe Renal Impairment	Voxilaprevir	Participants will receive a single dose of voxilaprevir on Day 1.

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast	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	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.
PK Parameter of Voxilaprevir: AUCinf	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	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.
PK Parameter of Voxilaprevir: Cmax	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	Cmax is defined as the maximum observed plasma concentration of drug. Data presented are unadjusted geometric means and confidence intervals.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAE) and Laboratory Abnormalities	First dose date to Day 31	The percentage of participants experiencing any TEAE or treatment-emergent laboratory abnormality was summarized.

Trial Locations

Locations (4)

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States

Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States

APEX GmbH; 🇩🇪 München, Germany

Christchurch Clinical Studies Trust Ltd; 🇳🇿 Christchurch, New Zealand