A Study Evaluating GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C

• Status: Completed
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Vesatolimod

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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