Chronic Hepatitis CPhase 1NCT01817985
A Phase 1 Study to Evaluate the Pharmacokinetics of GS-5816 in Subjects With Normal Hepatic Function and Moderate or Severe Hepatic Impairment
A Phase 1 study testing GS-5816 in people with Chronic Hepatitis C, run by Gilead Sciences at 6 sites in 2 countries.
Trial summary
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- GS-5816
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Mar 2013to Aug 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Diagnosis of chronic (> 6 months), hepatic impairment.
- In the opinion of the Investigator, be in good health.
Who cannot join
- Severe hepatic encephalopathy.
- Prior placement of a portosystemic shunt.
- Hepatorenal or hepatopulmonary syndrome.
- Suspicion of hepatocellular carcinoma.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Investigational Site
Miami, Florida, 33014
Investigational Site
Miami, Florida, 33169
Investigational Site
Orlando, Florida, 32806
Investigational Site
Orlando, Florida, 32809
Investigational Site
San Antonio, Texas, 78215
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 Hepatic Function and Moderate or Severe Hepatic Impairment
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.
- Conditions
- Chronic Hepatitis C
- Being tested
- GS-5816
- Keywords
- Hepatitis C (HCV) Infection, Moderate Hepatic Impairment, Severe Hepatic Impairment
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-5816Drug
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | (N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816. Receives: Drug: GS-5816 |
| Cohort 2 | Experimental | (N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816. Receives: Drug: GS-5816 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters of GS-5816
The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.
Measured: Up to one year
Secondary outcomes (1)
Incidences of adverse events and laboratory abnormalities
The secondary outcome measure is the number of incidences of adverse events and laboratory abnormalities.
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies 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)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Diana Brainard, M.D., Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817985
- Sponsor's protocol ID
- GS-US-281-0112
- Status last verified
- Aug 2013
- First submitted
- 20 Mar 2013
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. 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 Hepatic Function and Moderate or Severe Hepatic Impairment
- ClinicalTrials.gov ID
- NCT01817985
- Acronym / sponsor ID
- GS-US-281-0112
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C (HCV) Infection, Moderate Hepatic Impairment, Severe Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 26 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1 Open-Label, Parallel-Group, Single-Dose Study to evaluate the Pharmacokinetics of GS-5816 in subjects with normal hepatic function and moderate or severe hepatic impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: GS-5816(N = 20 Moderately Impaired / Normal Hepatic Function) 100 mg GS-5816. |
| Cohort 2 | Experimental | Drug: GS-5816(N = 20 Severely Impaired / Normal Hepatic Function) up to 100 mg GS-5816. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of chronic (> 6 months), hepatic impairment.
- In the opinion of the Investigator, be in good health.
Key exclusion criteria (4 listed)
- Severe hepatic encephalopathy.
- Prior placement of a portosystemic shunt.
- Hepatorenal or hepatopulmonary syndrome.
- Suspicion of hepatocellular carcinoma.
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 |
|---|---|---|
| GS-5816 | Drug | Cohort 1, Cohort 2 |
Primary outcome
Pharmacokinetic parameters of GS-5816
Time frame: Up to one year
The primary outcome measure is the pharmacokinetic parameters of GS-5816 which will include AUClast, AUCinf, and Cmax.
1 secondary outcome
Incidences of adverse events and laboratory abnormalities
Time frame: Up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2013.
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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.
Diana Brainard, M.D. study director
Gilead Sciences
6 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 GS-5816 in people with Chronic Hepatitis C, run by Gilead Sciences at 6 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 2 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 29 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Puerto Rico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 parameters of GS-5816 (time frame: Up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Aug 2013.