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

Gilead Sciences51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Hepatitis C

Interventions

Single Ascending Dose Cohorts GS-9620DRUG

This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.

Multiple Ascending Dose Cohorts GS-9620DRUG

This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (11)

Woodland International Research Group

Little Rock, Arkansas, United States

Avail Clinical Research, LLC

DeLand, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Outcomes

Primary Outcomes

Incidence of adverse events in single and multiple doses of GS-9620

Assessments include adverse events, laboratory abnormalities, 12-lead ECG abnormalities and interval measurements, and vital sign measurements

Time frame: Periodically Day 1 to 6 months

Secondary Outcomes

Assessment of plasma drug concentrations of GS-9620 using non-compartmental methods

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.

Time frame: Day 1 and Day 8

Measurement of pharmacodynamic markers (cytokines and interferon-stimulated genes [ISGs])

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 15

Time frame: Days 1, 2, 3, 5, 8

Reduction of hepatitis C (HCV) RNA viral load from baseline

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.

Time frame: Screening, Baseline, Day 8 or 15

Data from ClinicalTrials.gov

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