NCT02002767

Brief Summary

The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_1

Geographic Reach
2 countries

5 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

December 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
10 days until next milestone

Study Start

First participant enrolled

December 16, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2014

Completed
6.4 years until next milestone

Results Posted

Study results publicly available

November 16, 2020

Completed
Last Updated

November 16, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

December 2, 2013

Results QC Date

October 20, 2020

Last Update Submit

October 20, 2020

Conditions

Hepatitis C Virus

Outcome Measures

Primary Outcomes (3)

  • Pharmacokinetic (PK) Parameter of Velpatasvir: AUClast

    AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.

    Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1

  • PK Parameter of Velpatasvir: AUCinf

    AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.

    Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1

  • PK Parameter of Velpatasvir: Cmax

    Cmax is defined as the maximum observed plasma concentration of drug.

    Pre-dose (≤ 5 min), 0.5, 1, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 18, 24, 48, 72, 96, and 120 hours post-dose on Day 1

Secondary Outcomes (3)

  • Percentage of Participants Experiencing Treatment-Emergent Adverse Events

    First dose date plus 30 days

  • Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities

    First dose date plus 30 days

  • Percentage Protein Binding of Velpatasvir

    2 or 3 hours post-dose on Day 1

Study Arms (2)

Participants with renal impairment

EXPERIMENTAL

Participants with severe renal impairment will receive a single dose of velpatasvir.

Drug: Velpatasvir

Participants with normal renal function

ACTIVE COMPARATOR

Participants with normal renal function will receive a single dose of velpatasvir.

Drug: Velpatasvir

Interventions

VelpatasvirDRUG

Velpatasvir 100 mg (2 x 50 mg tablets) administered orally

Also known as: GS-5816
Participants with normal renal functionParticipants with renal impairment

Eligibility Criteria

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

You may qualify if:

  • General good health with stable chronic kidney disease in Severe Renal Impairment Group
  • Screening labs within defined thresholds
  • Creatinine clearance must be \< 30 mL/min for Severe Renal Impairment group, and ≥ 90 mL/min for Normal Renal Function group

You may not qualify if:

  • Females who are pregnant or nursing, or males who have a pregnant partner
  • Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV
  • History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Miami, Florida, 33014, United States

Location

Unknown Facility

Orlando, Florida, 32809, United States

Location

Unknown Facility

Saint Paul, Minnesota, 55114, United States

Location

Unknown Facility

San Antonio, Texas, 78215, United States

Location

Unknown Facility

Christchurch, 08011, New Zealand

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

velpatasvir

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

    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

December 2, 2013

First Posted

December 6, 2013

Study Start

December 16, 2013

Primary Completion

June 9, 2014

Study Completion

June 9, 2014

Last Updated

November 16, 2020

Results First Posted

November 16, 2020

Record last verified: 2020-10

Locations

US(4)NZ(1)