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

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ClinicalTrials.gov Identifier: NCT02402452
Recruitment Status : Completed
First Posted : March 30, 2015
Results First Posted : March 20, 2020
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HCV Infection Drug: Voxilaprevir Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 5, 2015
Actual Primary Completion Date : September 28, 2015
Actual Study Completion Date : September 28, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Experimental: Normal Renal Function
Participants will receive a single dose of voxilaprevir on Day 1.
Drug: Voxilaprevir
100 mg tablet administered orally
Other Name: GS-9857

Experimental: Severe Renal Impairment
Participants will receive a single dose of voxilaprevir on Day 1.
Drug: Voxilaprevir
100 mg tablet administered orally
Other Name: GS-9857




Primary Outcome Measures :
  1. Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast [ 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 ]
    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.

  2. PK Parameter of Voxilaprevir: AUCinf [ 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 ]
    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.

  3. PK Parameter of Voxilaprevir: Cmax [ 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 ]
    Cmax is defined as the maximum observed plasma concentration of drug. Data presented are unadjusted geometric means and confidence intervals.


Secondary Outcome Measures :
  1. Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAE) and Laboratory Abnormalities [ Time Frame: First dose date to Day 31 ]
    The percentage of participants experiencing any TEAE or treatment-emergent laboratory abnormality was summarized.



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402452


Locations
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United States, Florida
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
United States, Texas
Texas Liver Institute
San Antonio, Texas, United States, 78215
Germany
APEX GmbH
München, Germany, 81241
New Zealand
Christchurch Clinical Studies Trust Ltd
Christchurch, New Zealand, 8011
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director, MD, PhD Gilead Sciences
Publications of Results:
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.

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02402452    
Other Study ID Numbers: GS-US-338-1125
2015-000341-23 ( EudraCT Number )
First Posted: March 30, 2015    Key Record Dates
Results First Posted: March 20, 2020
Last Update Posted: March 20, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Hepatitis C
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases