A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C
- Conditions
- Hepatitis C
- Interventions
- Drug: Single Ascending Dose Cohorts GS-9620Drug: Multiple Ascending Dose Cohorts GS-9620
- Registration Number
- NCT01591668
- Lead Sponsor
- Gilead Sciences
- Brief Summary
Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Dose escalation or repetition will be governed by pre-specified safety and activity rules. Subjects will be confined on either days 1-3 and/or days 8-10. Follow-up visits are also required periodically through day 43. Study procedures involve taking blood samples for pharmacokinetic, pharmacodynamic, virologic, and safety assessments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- Males and Females 18-65 years old
- Chronic HCV infection for at least 6 months, treatment naive
- HCV Viral load > 100,000 IU/mL at Screening
- Monoinfection with HCV 1 genotype
- Hepatitis B surface antigen negative
- Screening ECG without clinically significant abnormalities
- BMI 18-33 kg/m^2
- Creatinine clearing > 70 mL/min
- Negative pregnancy test at screening
- Pregnant or lactating subjects
- Co-infection with hepatitis B virus (HBV) or HIV
- History of Gilberts disease
- Particular abnormal laboratory parameters
- Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), malignancy, hemoglobinopathy, retinal disease, and those who are immunosuppressed
- Evidence of hepatocellular carcinoma
- On-going alcohol abuse
- Positive uring drug screen
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 0.3mg GS-9620 Single Ascending Dose Cohorts GS-9620 - 1mg GS-9620 Single Ascending Dose Cohorts GS-9620 - 2mg GS-9620 Single Ascending Dose Cohorts GS-9620 - 4mg GS-9620 Single Ascending Dose Cohorts GS-9620 - 0.3mg GS-9620 QW x 2 doses Multiple Ascending Dose Cohorts GS-9620 - 1mg GS-9620 QW x 2 doses Multiple Ascending Dose Cohorts GS-9620 - 2mg GS-9620 QW x 2 doses Multiple Ascending Dose Cohorts GS-9620 - 4mg GS-9620 QW x 2 doses Multiple Ascending Dose Cohorts GS-9620 -
- Primary Outcome Measures
Name Time Method Incidence of adverse events in single and multiple doses of GS-9620 Periodically Day 1 to 6 months Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital sign measurements
- Secondary Outcome Measures
Name Time Method Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods Day 1 and Day 8 Single ascending dose (SAD) cohorts: serial blood samples will be collected on Day 1 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 48, and 96 hours post-dose.
Multiple ascending dose (MAD) cohorts: serial blood samples will be collected on Day 8 at 0 (pre-dose), 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs]) Days 1, 2, 3, 5, 8 SAD cohorts: Whole blood and serum for pharmacodynamic (PD) assessments (RNA and cytokine analysis) will be drawn on Day 1: Pre-dose and 8-hour Post-dose, Day 2, Day 3, Day 5, Day 8
MAD cohorts: Whole blood and serum for PD assessments (RNA and cytokine analysis) will be drawn on Day 1: Pre-dose and 8-hours Post-dose, Day 2, Day 3, Day 5, Day 8: Pre-dose and 8 hours Post-dose, Day 9, Day 10, Day 12, and Day 15Reduction of hepatitis C (HCV) RNA viral load from baseline Screening, Baseline, Day 8 or 15 SAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, 8 and both Follow-up Visits.
MAD cohorts: HCV viral load will be drawn at Day 1: Pre-dose, Day 2, 3, 5, Day 8: Pre-dose, 9, 10, 15, and both Follow-Up Visits.
Trial Locations
- Locations (10)
Avail Clinical Research, LLC
🇺🇸DeLand, Florida, United States
Fundacion De Investigacion De Diego
🇵🇷Santurce, Puerto Rico
CliniLabs
🇺🇸New York, New York, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
Kansas City Gastroenterology and Hepatology
🇺🇸Kansas City, Missouri, United States
CRI Worldwide, LLC
🇺🇸Philadelphia, Pennsylvania, United States
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Lifetree Clinical Research
🇺🇸Salt Lake City, Utah, United States
Woodland International Research Group
🇺🇸Little Rock, Arkansas, United States