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

Status:	Completed
Conditions:	Hepatitis
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	Any
Updated:	10/21/2012
Start Date:	March 2012
End Date:	December 2012
Contact:	Uri Lopatin, MD
Email:	Uri.Lopatin@gilead.com

A Double-Blind, Randomized, Placebo-Controlled, Single and Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Antiviral Activity of GS-9620 in Treatment Naive Subjects With Chronic Hepatitis C Virus Infection

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.

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 > 70mL/min

- Negative pregnancy test at screening

Exclusion Criteria:

- Pregnant or lactating subjects

- Co-infection with HBV or HIV

- History of Gilberts disease

- Particular abnormal laboratory parameters

- Diagnosis of autoimmune disease, poorly controlled diabetes, significant psychiatric
illness, severe COPD, malignancy, hemoglobinopaty, retinal disease, and those who are
immunosuppressed

- Evidence of hepatocellular carcinoma

- On-going alcohol abuse

- Positive uring drug screen

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