NCT02402452

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2015

Shorter than P25 for phase_1

Geographic Reach
3 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 30, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 5, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2015

Completed
4.5 years until next milestone

Results Posted

Study results publicly available

March 20, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

March 25, 2015

Results QC Date

March 4, 2020

Last Update Submit

March 4, 2020

Conditions

HCV Infection

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (1)

  • Percentage of Participants Who Experienced Treatment-Emergent Adverse Events (TEAE) and Laboratory Abnormalities

    First dose date to Day 31

Study Arms (2)

Normal Renal Function

EXPERIMENTAL

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

Drug: Voxilaprevir

Severe Renal Impairment

EXPERIMENTAL

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

Drug: Voxilaprevir

Interventions

VoxilaprevirDRUG

100 mg tablet administered orally

Also known as: GS-9857
Normal Renal FunctionSevere Renal Impairment

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

APEX GmbH

München, 81241, Germany

Location

Christchurch Clinical Studies Trust Ltd

Christchurch, 8011, New Zealand

Location

Related 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 Congress; 2016; Barcelona, Spain.

    RESULT

MeSH Terms

Conditions

Hepatitis C

Interventions

voxilaprevir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Gilead Clinical Study Information Center
Organization
Gilead Sciences
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)

Study Officials

  • Gilead Study Director, MD, PhD

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2015

First Posted

March 30, 2015

Study Start

May 5, 2015

Primary Completion

September 28, 2015

Study Completion

September 28, 2015

Last Updated

March 20, 2020

Results First Posted

March 20, 2020

Record last verified: 2020-03

Locations

NZ(1)DE(1)US(2)