HCV InfectionPhase 1NCT02397707

Pharmacokinetics of Voxilaprevir in Adults With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

A Phase 1 study testing Voxilaprevir in people with HCV Infection, run by Gilead Sciences at 4 sites in 3 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: HCV Infection
What is being tested?: Voxilaprevir
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 4 sitesin 3 countries
Study dates: 24 Mar 2015to 4 Mar 2016
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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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 moderate hepatic impairment:
Diagnosis of chronic (> 6 months) hepatic impairment
Score on the Child-Pugh-Turcotte (CPT) scale of 7-9 at screening (Child Pugh Class B).

Show all 11Show fewer

For individuals with severe hepatic impairment:
Diagnosis of chronic (> 6 months) hepatic impairment
Score on the CPT scale of 10-15 at screening (Child Pugh Class C)
For individuals with normal hepatic function:
Hepatitis C Virus (HCV) antibody and hepatitis B surface antigen negative

Who cannot join

All individuals:
Pregnant or nursing female or male with pregnant female partner
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 moderate or severe hepatic impairment:
Active HCV infection

Show all 15Show fewer

Current hepatic encephalopathy
Variceal bleeding in the last 6 months unless banded
Prior placement of a portosystemic shunt
History of hepatorenal or hepatopulmonary syndrome
Spontaneous bacterial peritonitis currently or within the last 6 months
Hospitalization within the last 2 months related to cirrhosis
Confirmed hypotension
Suspicion of hepatocellular carcinoma
Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

4 sites in 3 countries.

Country

City, postcode or hospital

4 sites in 3 countries

United States2 sites

Orlando Clinical Research Center
Orlando, Florida, 32809
Texas Liver Institute
San Antonio, Texas, 78215

Other trials in United States

Germany1 site

APEX GmbH
München, 81241

Other trials in Germany

New Zealand1 site

Auckland Clinical Studies
Auckland, 1142

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-9857 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment

The primary objective of this study is to evaluate the pharmacokinetics (PK), safety, and tolerability of a single dose of voxilaprevir (formerly GS-9857) in participants with normal hepatic function, moderate hepatic impairment and severe hepatic impairment. Participants in the healthy control group will be matched to participants with impaired hepatic function by gender, age (± 10 years), and body mass index (± 15%).

Conditions: HCV Infection
Being tested: Voxilaprevir
Medical subject headings: Hepatitis C

What participants receive

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

VoxilaprevirDrug
Also called GS-9857
100 mg tablet administered orally

Study groups in NCT02397707
Study group	Role	What they receive
Moderate Hepatic Impaired	Experimental	Participants with moderate hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1. Receives: Drug: Voxilaprevir
Severe Hepatic Impaired	Experimental	Participants with severe hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1. Receives: Drug: Voxilaprevir

What is being measured

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

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.
Measured: 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 post-dose
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.
Measured: 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.
Measured: 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

Timeline

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

24 Mar 20154 Mar 2016

First posted25 Mar 2015 (estimated)
Study start24 Mar 2015
Primary completion4 Mar 2016
Study completion4 Mar 2016

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HCV InfectionStudies 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: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02397707
Sponsor's protocol ID: GS-US-338-1126
Other IDs: 2015-000342-30, 2015
Status last verified: Apr 2020
First submitted: 20 Mar 2015
Last updated: 9 Apr 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lawitz E, Marbury T, Kirby BJ, Au NT, Mathias A, Stamm LM, et al. The Effect of Renal or Hepatic Impairment on the Pharmacokinetics of GS-9857, A Pan-Genotypic HCV NS3/4A Protease Inhibitor [Abstract FRI-167]. J Hepatology 2016:S613-S4.

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

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
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
HCV Infection
Recruiting
HIV/HBV/HCV Triple Screening in Primary Care
HIV, HBV (Hepatitis B Virus)

All HCV Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 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-9857 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
ClinicalTrials.gov ID: NCT02397707
Acronym / sponsor ID: GS-US-338-1126
Conditions: HCV Infection
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Gilead SciencesIndustry (pharma, biotech, devices)
Study start: 24 Mar 2015 (actual)
Primary completion: 4 Mar 2016 (actual)
Study completion: 4 Mar 2016 (actual)
First posted: 25 Mar 2015 (estimated)
Results: Posted 20 Mar 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
Moderate Hepatic Impaired	Experimental	Drug: VoxilaprevirParticipants with moderate hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1.
Severe Hepatic Impaired	Experimental	Drug: VoxilaprevirParticipants with severe hepatic impairment and matched healthy controls will receive a single dose of voxilaprevir on Day 1.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

All individuals:
For individuals with moderate hepatic impairment:
For individuals with severe hepatic impairment:
For individuals with normal hepatic function:

Key exclusion criteria (15 listed)

All individuals:
For individuals with moderate or severe hepatic impairment:
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
VoxilaprevirAlso: GS-9857100 mg tablet administered orally	Drug	Moderate Hepatic Impaired, Severe Hepatic Impaired

Primary outcome

Pharmacokinetic (PK) Parameter of Voxilaprevir: AUClast
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 post-dose
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.
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.
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.

Results and safety

Results posted to the registry on 20 Mar 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 Hepatic Function	14	14
Moderate Hepatic Impairment (MHI)	10	10
Severe Hepatic Impairment (SHI)	9	9

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

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 post-dose. Geometric mean (95% Confidence Interval). Unit: h*ng/mL

Measure	Moderate Hepatic Impairment (MHI) n = 10	Severe Hepatic Impairment (SHI) n = 9	Normal Hepatic Function (Matched Control for MHI) n = 10	Normal Hepatic Function (Matched Controls for SHI) n = 9
Value	2058.5 (1034 to 4098.1)	3872.5 (2173.1 to 6901.2)	500.1 (307 to 814.6)	601.2 (372.8 to 969.6)

Moderate Hepatic Impairment (MHI) vs Normal Hepatic Function (Matched Control for MHI): Geometric Least-Square Mean (GLSM)Ratio%: 411.62 (90% CI 214.72 to 789.08)
Severe Hepatic Impairment (SHI) vs Normal Hepatic Function (Matched Controls for SHI): GLSM Ratio (%): 644.15 (90% CI 364.67 to 1137.82)

Population analysed: PK Analysis Set included all enrolled participants who took at least 1 dose of study drug and had at least 1 nonmissing postdose concentration value reported by the PK laboratory for the corresponding analyte. Five of the same participants with normal hepatic function served as matched controls for the MHI and SHI Arms/Groups.

Primary outcome: 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. Geometric mean (95% Confidence Interval). Unit: h*ng/mL

Measure	Moderate Hepatic Impairment (MHI) n = 10	Severe Hepatic Impairment (SHI) n = 9	Normal Hepatic Function (Matched Control for MHI) n = 10	Normal Hepatic Function (Matched Controls for SHI) n = 9
Value	2227.1 (1122 to 4420.7)	4107.5 (2331.7 to 7235.7)	557.8 (351.8 to 884.6)	685 (426.1 to 1101.2)

Moderate Hepatic Impairment (MHI) vs Normal Hepatic Function (Matched Control for MHI): GLSM Ratio (%): 399.24 (90% CI 210.89 to 755.81)
Severe Hepatic Impairment (SHI) vs Normal Hepatic Function (Matched Controls for SHI): GLSM Ratio (%): 599.63 (90% CI 342.36 to 1050.22)

Population analysed: Participants in the PK Analysis Set were analyzed. Five of the same participants with normal hepatic function served as matched controls for the MHI and SHI Arms/Groups.

Primary outcome: 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. Geometric mean (95% Confidence Interval). Unit: ng/mL

Measure	Moderate Hepatic Impairment (MHI) n = 10	Severe Hepatic Impairment (SHI) n = 9	Normal Hepatic Function (Matched Control for MHI) n = 10	Normal Hepatic Function (Matched Controls for SHI) n = 9
Value	189.7 (85.2 to 422.3)	370.8 (183.6 to 749)	56.1 (38.2 to 82.2)	51.9 (35.1 to 76.9)

Moderate Hepatic Impairment (MHI) vs Normal Hepatic Function (Matched Control for MHI): GLSM Ratio (%): 338.41 (90% CI 168.96 to 677.79)
Severe Hepatic Impairment (SHI) vs Normal Hepatic Function (Matched Controls for SHI): GLSM Ratio (%): 713.92 (90% CI 384.07 to 1327.06)

Population analysed: Participants in the PK Analysis Set were analyzed. Five of the same participants with normal hepatic function served as matched controls for the MHI and SHI Arms/Groups.

Adverse events

Time frame: First dose date up to 31 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normal Hepatic Function	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14
Moderate Hepatic Impairment (MHI)	0 of 10 (0%)	3 of 10 (30%)	0 of 10
Severe Hepatic Impairment (SHI)	0 of 9 (0%)	1 of 9 (11.1%)	0 of 9

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationLawitz E, Marbury T, Kirby BJ, Au NT, Mathias A, Stamm LM, et al. The Effect of Renal or Hepatic Impairment on the Pharmacokinetics of GS-9857, A Pan-Genotypic HCV NS3/4A Protease Inhibitor [Abstract FRI-167]. J Hepatology 2016:S613-S4.

Related trials for HCV Infection

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruiting
HIV/STI/HCV Testing and Overdose Prevention Among Survivors of Sex Trafficking
HIV Testing, STI
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
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
HCV Infection
Recruiting
HIV/HBV/HCV Triple Screening in Primary Care
HIV, HBV (Hepatitis B Virus)

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

4 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Voxilaprevir in people with HCV Infection, run by Gilead Sciences at 4 sites in 3 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 11 inclusion and 15 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 9 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States, Germany, 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 20 Mar 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 Voxilaprevir: AUClast (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 post-dose). 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 NCT02397707, which also lists 1 linked publication.

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 9 Apr 2020.