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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: Single Ascending Dose Cohorts GS-9620; Drug: Multiple Ascending Dose Cohorts GS-9620

Study type: Interventional

Funder types: Industry

Identifiers

NCT01591668

GS-US-243-0102

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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51 participants in 8 patient groups

0.3mg GS-9620

Experimental group

Treatment:

Drug: Single Ascending Dose Cohorts GS-9620

1mg GS-9620

Experimental group

Treatment:

Drug: Single Ascending Dose Cohorts GS-9620

2mg GS-9620

Experimental group

Treatment:

Drug: Single Ascending Dose Cohorts GS-9620

4mg GS-9620

Experimental group

Treatment:

Drug: Single Ascending Dose Cohorts GS-9620

0.3mg GS-9620 QW x 2 doses

Experimental group

Treatment:

Drug: Multiple Ascending Dose Cohorts GS-9620

1mg GS-9620 QW x 2 doses

Experimental group

Treatment:

Drug: Multiple Ascending Dose Cohorts GS-9620

2mg GS-9620 QW x 2 doses

Experimental group

Treatment:

Drug: Multiple Ascending Dose Cohorts GS-9620

4mg GS-9620 QW x 2 doses

Experimental group

Treatment:

Drug: Multiple Ascending Dose Cohorts GS-9620