Hepatitis C VirusPhase 1NCT02002767

Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment

A Phase 1 study testing Velpatasvir in people with Hepatitis C Virus, run by Gilead Sciences at 5 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 79 yearsHealthy volunteers can take part
Conditions the study is for: Hepatitis C Virus
What is being tested?: Velpatasvir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 5 sitesin 2 countries
Study dates: 16 Dec 2013to 9 Jun 2014
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 79 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

5 sites in 2 countries.

Country

City, postcode or hospital

5 sites in 2 countries

United States4 sites

Study site
Miami, Florida, 33014
Study site
Orlando, Florida, 32809
Study site
Saint Paul, Minnesota, 55114
Study site
San Antonio, Texas, 78215

Other trials in United States

New Zealand1 site

Study site
Christchurch, 08011

Other trials in New Zealand

About this study

Official title: A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Renal Function and Severe Renal Impairment

Conditions: Hepatitis C Virus
Being tested: Velpatasvir
Medical subject headings: Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

VelpatasvirDrug
Also called GS-5816
Velpatasvir 100 mg (2 x 50 mg tablets) administered orally

Study groups in NCT02002767
Study group	Role	What they receive
Participants with renal impairment	Experimental	Participants with severe renal impairment will receive a single dose of velpatasvir. Receives: Drug: Velpatasvir
Participants with normal renal function	Active comparator	Participants with normal renal function will receive a single dose of velpatasvir. Receives: Drug: Velpatasvir

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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
Treatment-emergent adverse events (TEAEs) were defined as any adverse events (AEs) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug.
Measured: First dose date plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
A treatment-emergent laboratory abnormality was defined as an increase of at least 1 abnormality grade from baseline and occurring after the first dose of study drug and within 30 days after last study drug administration. The severity of laboratory abnormalities was assessed as Grade 0, 1 (mild), 2 (moderate), 3 (severe), or 4 (potentially life threatening).
Measured: First dose date plus 30 days
Percentage Protein Binding of Velpatasvir
Mean velpatasvir protein binding (percentage free and percentage bound) was determined in all participants at 2 or 3 hours post-dose. Protein binding was assessed at Tmax whenever possible or at the time point closest to Tmax for each participant.
Measured: 2 or 3 hours post-dose on Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Dec 20139 Jun 2014

First posted6 Dec 2013 (estimated)
Study start16 Dec 2013
Primary completion9 Jun 2014
Study completion9 Jun 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
More trials run by Gilead SciencesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02002767
Sponsor's protocol ID: GS-US-281-1056
Other IDs: 2013-004113-41
Status last verified: Oct 2020
First submitted: 2 Dec 2013
Last updated: 16 Nov 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hepatitis C Virus trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Renal Function and Severe Renal Impairment
ClinicalTrials.gov ID: NCT02002767
Acronym / sponsor ID: GS-US-281-1056
Conditions: Hepatitis C Virus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 16 Dec 2013 (actual)
Primary completion: 9 Jun 2014 (actual)
Study completion: 9 Jun 2014 (actual)
First posted: 6 Dec 2013 (estimated)
Results: Posted 16 Nov 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Participants with renal impairment	Experimental	Drug: VelpatasvirParticipants with severe renal impairment will receive a single dose of velpatasvir.
Participants with normal renal function	Active comparator	Drug: VelpatasvirParticipants with normal renal function will receive a single dose of velpatasvir.

Who may qualify

Ages: 18 to 79 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
VelpatasvirAlso: GS-5816Velpatasvir 100 mg (2 x 50 mg tablets) administered orally	Drug	Participants with normal renal function, Participants with renal impairment

Primary outcome

Pharmacokinetic (PK) Parameter of Velpatasvir: AUClast
Time frame: 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
AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.
PK Parameter of Velpatasvir: AUCinf
Time frame: 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
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
PK Parameter of Velpatasvir: Cmax
Time frame: 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
Cmax is defined as the maximum observed plasma concentration of drug.

3 secondary outcomes

Percentage of Participants Experiencing Treatment-Emergent Adverse Events
Time frame: First dose date plus 30 days
Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities
Time frame: First dose date plus 30 days
Percentage Protein Binding of Velpatasvir
Time frame: 2 or 3 hours post-dose on Day 1

Results and safety

Results posted to the registry on 16 Nov 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normal Renal Function	9	9
Severe Renal Impairment	10	10

Primary outcome: Pharmacokinetic (PK) Parameter of Velpatasvir: AUClast

Time frame: 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. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Normal Renal Function n = 9	Severe Renal Impairment n = 10
Value	5597.8 (1749.18)	7971.7 (2531.09)

Normal Renal Function vs Severe Renal Impairment: Geometric Least Squares Mean(GLSM) Ratio: 149.05 (90% CI 116.62 to 190.49)

Population analysed: The PK analysis set included all enrolled and treated participants who have evaluable PK profiles for velpatasvir.

Primary outcome: PK Parameter of Velpatasvir: AUCinf

Time frame: 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. Mean (Standard Deviation). Unit: h*ng/mL

Measure	Normal Renal Function n = 9	Severe Renal Impairment n = 10
Value	5651.6 (1763.12)	8108.3 (2628.18)

Normal Renal Function vs Severe Renal Impairment: GLSM Ratio: 149.90 (90% CI 116.97 to 192.11)

Population analysed: Participants in the PK Analysis Set were analyzed.

Primary outcome: PK Parameter of Velpatasvir: Cmax

Time frame: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	Normal Renal Function n = 9	Severe Renal Impairment n = 10
Value	702.7 (197.20)	732.4 (176.19)

Normal Renal Function vs Severe Renal Impairment: GLSM Ratio: 110.85 (90% CI 90.76 to 135.38)

Population analysed: Participants in the PK Analysis Set were analyzed.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: First dose date plus 30 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Renal Function	0 of 9 (0%)	0 of 9 (0%)	0 of 9
Severe Renal Impairment	0 of 10 (0%)	2 of 10 (20%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis C Virus

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Evaluation of Patients With Liver Disease
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Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Gilead Study Director study director

Gilead Sciences

5 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Velpatasvir in people with Hepatitis C Virus, run by Gilead Sciences at 5 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetic (PK) Parameter of Velpatasvir: AUClast (time frame: 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02002767.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2020.