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Completed

NCT Number: NCT02402452

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

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.

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Key information

Conditions

HCV Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

APEX GmbH, München, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Voxilaprevir

Drug

100 mg tablet administered orally

Other names: GS-9857

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 30, 2015
Registry last updated
Mar 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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