Hepatitis C, ChronicPhase 1NCT01316237
A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection
A Phase 1 study testing GS-6620, GS-6620 tablet, 450 mg BID and GS-6620 tablet in people with Hepatitis C, Chronic, run by Gilead Sciences at 13 sites in 2 countries.
Trial summary
A Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects with Chronic Hepatitis C Virus Infection. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- GS-6620, GS-6620 tablet, 450 mg BID and GS-6620 tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 13 sitesin 2 countries
- Study dates
- Jan 2011to Jan 2012
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult subjects (18-60 years of age or up to 64 years of age with approval)
- Documented chronic HCV infection to be of at least 6 months duration and plasma HCV RNA ≥ 5 log10 IU/mL at screening.
- HCV treatment naïve
- Estimated creatinine clearance ≥ 80 mL/min,
- QTcF interval ≤ 450 msec, QRS duration < 100 msec, PR interval < 220 msec,
- Body mass index (BMI) of 19.0 to 34.0 kg/m2, inclusive.
- Eligible subjects must also be HCV treatment-naïve.
Who cannot join
- Subjects with prior documentation of cirrhosis, excessive current alcohol intake, any evidence of hepatocellular carcinoma (i.e., α-fetoprotein > 50 ng/mL or by any other standard of care measure)
- Urine drug screen positive for illicit/illegal drugs
- ALT and AST levels > 5 times the upper limit of the normal range (ULN)
- Direct bilirubin > ULN, clinical or other laboratory evidence of hepatic decompensation (i.e., platelets < 100,000/mm3, prothrombin time ≥ 1.5 × ULN and albumin < 3.5 g/dL) are not eligible for study participation.
- Subjects with an absolute neutrophil count (ANC) < 1,000 cells/mm3 (< 750 cells/mm3 for black or African-American subjects), hemoglobin (Hb) < 11 g/dL,
- Coinfected with hepatitis B virus (HBV), human immunodeficiency virus (HIV), or another HCV genotype (other than type 1 for Cohorts 1-5 and type 2 or 3 for Cohort 6) are not eligible for study participation.
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- Evidence of hepatocellular carcinoma
- Any sign of decompensated liver disease, including prothrombin time ≥ 1.5 X ULN, platelets < 100,000/mm3 or albumin < 3.5 g/dL at screening OR current or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy or variceal hemorrhage)
- History of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
- History of a primary gastrointestinal disorder that could interfere with the absorption of the study drug or that could interfere with normal gastrointestinal anatomy or motility
Trial locations and contacts
13 sites in 2 countries.
13 sites in 2 countries
United States12 sites
Advanced Clinical Research Institute
Anaheim, California, 92801
Avail Clinical Research, LLC
DeLand, Florida, 32720
University of Florida - Gainesville
Gainesville, Florida, 32608
St. Luke Episcopal Hospital
Houston, Texas, 77030
Axis Clinical Trials
Los Angeles, California, 90057
Orlando Immunology Center
Orlando, Florida, 32803
Orlando Clinical Research Center
Orlando, Florida, 32809
CRI Worldwide
Philadelphia, Pennsylvania, 19139
Lifetree Clinical Research, LC
Salt Lake City, Utah, 84106
Alamo Medical Research
San Antonio, Texas, 78215
Saint Louis University
St Louis, Missouri, 63104
Charles River Clinical Services Northwest
Tacoma, Washington, 98418
About this study
Official title: A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection
A Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects with Chronic Hepatitis C Virus Infection.
- Conditions
- Hepatitis C, Chronic
- Being tested
- GS-6620, GS-6620 tablet, 450 mg BID, GS-6620 tablet
- Keywords
- Hepatitis C, HCV, HCV RNA, Polymerase inhibitor, Treatment naïve, GS-6620
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GS-6620Drug
GS-6620 tablet, 50 mg QD
GS-6620Drug
GS-6620 tablet, 100 mg QD
GS-6620Drug
GS-6620 tablet, 300 mg QD
GS-6620Drug
GS-6620 tablet, 100 mg QD, Fasted
GS-6620Drug
GS-6620 tablet, 300 mg QD, Fasted
GS-6620Drug
GS-6620 tablet, 900 mg QD, Fasted
GS-6620 tablet, 450 mg BIDDrug
GS-6620 tablet, 450 mg BID
GS-6620 tabletDrug
GS-6620 tablet, 900mg , BID
GS-6620 tabletDrug
GS-6620 tablet, 900 mg
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 50 mg GS-6620 or placebo QD in the morning with food [total daily dose (TDD) = 50 mg] for 5 days Receives: Drug: GS-6620 |
| Cohort 2 | Other | (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2)
100 mg GS-6620 or placebo QD in the morning with food (TDD = 100 mg) for 5 days Receives: Drug: GS-6620 |
| Cohort 3 | Other | Cohort 3 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2)
300 mg GS 6620 or placebo QD in the morning with food (TDD = 300 mg) for 5 days Receives: Drug: GS-6620 |
| Cohort 4 | Other | Cohort 4 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2)
100 mg GS 6620 or placebo QD in the morning without food (TDD = 100 mg) for 5 days Receives: Drug: GS-6620 |
| Cohort 5 | Other | Cohort 5 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2)
300 mg GS 6620 or placebo QD in the morning without food (TDD = 300 mg) for 5 days Receives: Drug: GS-6620 |
| Cohort 6 | Other | Cohort 6 (N = 10, genotype 2 or genotype 3): (Active drug: 8, Matching Placebo: 2)
900 mg GS 6620 or placebo QD in the morning without food (TDD = 900 mg) for 5 days Receives: Drug: GS-6620 |
| Cohort 7 | Other | Cohort 7 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2)
450 mg GS 6620 or placebo, administered BID with food (TDD = 900 mg) for 5 days Receives: Drug: GS-6620 tablet, 450 mg BID |
| Cohort 9 | Other | Cohort 9 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2)
900 mg GS 6620 or placebo BID in the with food (TDD = 1800 mg) for 5 days Receives: Drug: GS-6620 tablet |
| Cohort 11 | Other | Cohort 11 (N = 10, genotype 1 : (Active drug: 8, Matching Placebo: 2)
Up to 450 mg GS-6620 or placebo as an oral solution, BID, 12 hours apart in the fasted state, 2 hours after a meal (up to TDD = up to 900 mg) for 5 days. Receives: Drug: GS-6620 tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with adverse events as a measure of safety and tolerability.
Number of subjects with HCV RNA viral response as a measure of antiviral activity.
Secondary outcomes (1)
Concentrations and pharmacokinetic parameters of GS-6620 and its metabolites will be measured.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionOct 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies 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
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Stephen Rossi, PharmD, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01316237
- Sponsor's protocol ID
- GS-US-119-0101
- Status last verified
- Mar 2012
- First submitted
- 3 Feb 2011
- Last updated
- 26 Mar 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection
- ClinicalTrials.gov ID
- NCT01316237
- Acronym / sponsor ID
- GS-US-119-0101
- Conditions
- Hepatitis C, Chronic
- Keywords
- Hepatitis C, HCV, HCV RNA, Polymerase inhibitor, Treatment naïve, GS-6620
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 16 Mar 2011 (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.
A Double-Blind, Randomized, Placebo-Controlled, Multiple Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects with Chronic Hepatitis C Virus Infection.
Study design
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: GS-6620(N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 50 mg GS-6620 or placebo QD in the morning with food [total daily dose (TDD) = 50 mg] for 5 days |
| Cohort 2 | Other | Drug: GS-6620(N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 100 mg GS-6620 or placebo QD in the morning with food (TDD = 100 mg) for 5 days |
| Cohort 3 | Other | Drug: GS-6620Cohort 3 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 300 mg GS 6620 or placebo QD in the morning with food (TDD = 300 mg) for 5 days |
| Cohort 4 | Other | Drug: GS-6620Cohort 4 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 100 mg GS 6620 or placebo QD in the morning without food (TDD = 100 mg) for 5 days |
| Cohort 5 | Other | Drug: GS-6620Cohort 5 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 300 mg GS 6620 or placebo QD in the morning without food (TDD = 300 mg) for 5 days |
| Cohort 6 | Other | Drug: GS-6620Cohort 6 (N = 10, genotype 2 or genotype 3): (Active drug: 8, Matching Placebo: 2) 900 mg GS 6620 or placebo QD in the morning without food (TDD = 900 mg) for 5 days |
| Cohort 7 | Other | Drug: GS-6620 tablet, 450 mg BIDCohort 7 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 450 mg GS 6620 or placebo, administered BID with food (TDD = 900 mg) for 5 days |
| Cohort 9 | Other | Drug: GS-6620 tabletCohort 9 (N = 10, genotype 1): (Active drug: 8, Matching Placebo: 2) 900 mg GS 6620 or placebo BID in the with food (TDD = 1800 mg) for 5 days |
| Cohort 11 | Other | Drug: GS-6620 tabletCohort 11 (N = 10, genotype 1 : (Active drug: 8, Matching Placebo: 2) Up to 450 mg GS-6620 or placebo as an oral solution, BID, 12 hours apart in the fasted state, 2 hours after a meal (up to TDD = up to 900 mg) for 5 days. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Adult subjects (18-60 years of age or up to 64 years of age with approval)
- Documented chronic HCV infection to be of at least 6 months duration and plasma HCV RNA ≥ 5 log10 IU/mL at screening.
- HCV treatment naïve
- Estimated creatinine clearance ≥ 80 mL/min,
- QTcF interval ≤ 450 msec, QRS duration < 100 msec, PR interval < 220 msec,
Key exclusion criteria (10 listed)
- Subjects with prior documentation of cirrhosis, excessive current alcohol intake, any evidence of hepatocellular carcinoma (i.e., α-fetoprotein > 50 ng/mL or by any other standard of care measure)
- Urine drug screen positive for illicit/illegal drugs
- ALT and AST levels > 5 times the upper limit of the normal range (ULN)
- Direct bilirubin > ULN, clinical or other laboratory evidence of hepatic decompensation (i.e., platelets < 100,000/mm3, prothrombin time ≥ 1.5 × ULN and albumin < 3.5 g/dL) are not eligible for study participation.
- Subjects with an absolute neutrophil count (ANC) < 1,000 cells/mm3 (< 750 cells/mm3 for black or African-American subjects), hemoglobin (Hb) < 11 g/dL,
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-6620GS-6620 tablet, 50 mg QD | Drug | Cohort 1 |
| GS-6620GS-6620 tablet, 100 mg QD | Drug | Cohort 2 |
| GS-6620GS-6620 tablet, 300 mg QD | Drug | Cohort 3 |
| GS-6620GS-6620 tablet, 100 mg QD, Fasted | Drug | Cohort 4 |
| GS-6620GS-6620 tablet, 300 mg QD, Fasted | Drug | Cohort 5 |
| GS-6620GS-6620 tablet, 900 mg QD, Fasted | Drug | Cohort 6 |
| GS-6620 tablet, 450 mg BIDGS-6620 tablet, 450 mg BID | Drug | Cohort 7 |
| GS-6620 tabletGS-6620 tablet, 900mg , BID | Drug | Cohort 9 |
| GS-6620 tabletGS-6620 tablet, 900 mg | Drug | Cohort 11 |
Primary outcome
Number of subjects with adverse events as a measure of safety and tolerability.
Number of subjects with HCV RNA viral response as a measure of antiviral activity.
1 secondary outcome
Concentrations and pharmacokinetic parameters of GS-6620 and its metabolites will be measured.
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 26 Mar 2012.
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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.
Stephen Rossi, PharmD study director
Gilead Sciences
13 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-6620, GS-6620 tablet, 450 mg BID and GS-6620 tablet in people with Hepatitis C, Chronic, run by Gilead Sciences at 13 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 7 inclusion and 10 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 26 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Number of subjects with adverse events as a measure of safety and tolerability.. The study lists 2 primary outcomes in all. 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 26 Mar 2012.