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

Primary Purpose

HCV Infection

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Voxilaprevir
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HCV Infection

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Orlando Clinical Research Center
  • Texas Liver Institute
  • APEX GmbH
  • Christchurch Clinical Studies Trust Ltd

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Normal Renal Function

Severe Renal Impairment

Arm Description

Participants will receive a single dose of voxilaprevir on Day 1.

Participants will receive a single dose of voxilaprevir on Day 1.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 25, 2015
Last Updated
March 4, 2020
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02402452
Brief Title
Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
May 5, 2015 (Actual)
Primary Completion Date
September 28, 2015 (Actual)
Study Completion Date
September 28, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCV Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Renal Function
Arm Type
Experimental
Arm Description
Participants will receive a single dose of voxilaprevir on Day 1.
Arm Title
Severe Renal Impairment
Arm Type
Experimental
Arm Description
Participants will receive a single dose of voxilaprevir on Day 1.
Intervention Type
Drug
Intervention Name(s)
Voxilaprevir
Other Intervention Name(s)
GS-9857
Intervention Description
100 mg tablet administered orally
Primary Outcome Measure Information:
Title
Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast
Description
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.
Time Frame
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
Title
PK Parameter of Voxilaprevir: AUCinf
Description
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.
Time Frame
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
Title
PK Parameter of Voxilaprevir: Cmax
Description
Cmax is defined as the maximum observed plasma concentration of drug. Data presented are unadjusted geometric means and confidence intervals.
Time Frame
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 Outcome Measure Information:
Title
Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAE) and Laboratory Abnormalities
Description
The percentage of participants experiencing any TEAE or treatment-emergent laboratory abnormality was summarized.
Time Frame
First dose date to Day 31

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director, MD, PhD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
APEX GmbH
City
München
ZIP/Postal Code
81241
Country
Germany
Facility Name
Christchurch Clinical Studies Trust Ltd
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand

12. IPD Sharing Statement

Citations:
Citation
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 Congress; 2016; Barcelona, Spain.
Results Reference
result

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

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