A Study Evaluating the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-6620 in Treatment Naïve Subjects With Chronic Hepatitis C Virus Infection
Phase 1
Completed
- Conditions
- Hepatitis C, Chronic
- Interventions
- Registration Number
- NCT01316237
- Lead Sponsor
- Gilead Sciences
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cohort 1 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 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 4 GS-6620 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 Cohort 5 GS-6620 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 Cohort 6 GS-6620 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 Cohort 7 GS-6620 tablet, 450 mg BID 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 Cohort 9 GS-6620 tablet 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 Cohort 11 GS-6620 tablet 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. Cohort 3 GS-6620 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Concentrations and pharmacokinetic parameters of GS-6620 and its metabolites will be measured.
Trial Locations
- Locations (13)
Axis Clinical Trials
🇺🇸Los Angeles, California, United States
CRI Worldwide
🇺🇸Philadelphia, Pennsylvania, United States
Advanced Clinical Research Institute
🇺🇸Anaheim, California, United States
Avail Clinical Research, LLC
🇺🇸Deland, Florida, United States
Orlando Immunology Center
🇺🇸Orlando, Florida, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
University of Florida - Gainesville
🇺🇸Gainesville, Florida, United States
St. Luke Episcopal Hospital
🇺🇸Houston, Texas, United States
Saint Louis University
🇺🇸St. Louis, Missouri, United States
Lifetree Clinical Research, LC
🇺🇸Salt Lake City, Utah, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Charles River Clinical Services Northwest
🇺🇸Tacoma, Washington, United States
Fundacion De Investigacion De Diego
🇵🇷Puerto Rico, Puerto Rico