A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection
NCT ID: NCT01316237
Last Updated: 2012-03-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
90 participants
INTERVENTIONAL
2011-01-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Groups
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Cohort 1
(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
GS-6620
GS-6620 tablet, 50 mg QD
Cohort 2
(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
GS-6620
GS-6620 tablet, 100 mg QD
Cohort 3
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
GS-6620
GS-6620 tablet, 300 mg QD
Cohort 4
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
GS-6620
GS-6620 tablet, 100 mg QD, Fasted
Cohort 5
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
GS-6620
GS-6620 tablet, 300 mg QD, Fasted
Cohort 6
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
GS-6620
GS-6620 tablet, 900 mg QD, Fasted
Cohort 7
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
GS-6620 tablet, 450 mg BID
GS-6620 tablet, 450 mg BID
Cohort 9
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
GS-6620 tablet
GS-6620 tablet, 900mg , BID
Cohort 11
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.
GS-6620 tablet
GS-6620 tablet, 900 mg
Interventions
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GS-6620
GS-6620 tablet, 50 mg QD
GS-6620
GS-6620 tablet, 100 mg QD
GS-6620
GS-6620 tablet, 300 mg QD
GS-6620
GS-6620 tablet, 100 mg QD, Fasted
GS-6620
GS-6620 tablet, 300 mg QD, Fasted
GS-6620
GS-6620 tablet, 900 mg QD, Fasted
GS-6620 tablet, 450 mg BID
GS-6620 tablet, 450 mg BID
GS-6620 tablet
GS-6620 tablet, 900mg , BID
GS-6620 tablet
GS-6620 tablet, 900 mg
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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
18 Years
60 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Rossi, PharmD
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Advanced Clinical Research Institute
Anaheim, California, United States
Axis Clinical Trials
Los Angeles, California, United States
Avail Clinical Research, LLC
DeLand, Florida, United States
University of Florida - Gainesville
Gainesville, Florida, United States
Orlando Immunology Center
Orlando, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Saint Louis University
St Louis, Missouri, United States
CRI Worldwide
Philadelphia, Pennsylvania, United States
St. Luke Episcopal Hospital
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Lifetree Clinical Research, LC
Salt Lake City, Utah, United States
Charles River Clinical Services Northwest
Tacoma, Washington, United States
Fundacion De Investigacion De Diego
San Juan, PR, Puerto Rico
Countries
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Other Identifiers
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GS-US-119-0101
Identifier Type: -
Identifier Source: org_study_id
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