Overview

Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-9669 in Subjects With Chronic Hepatitis C Virus Infection

Status:
Completed
Trial end date:
2012-05-01
Target enrollment:
0
Participant gender:
All
Summary
This is a research study to evaluate the safety, tolerability and anti-viral activity of GS-9669 in patients with Hepatitis C infection.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Gilead Sciences
Treatments:
Antiviral Agents
Criteria
Inclusion Criteria:

- Adult subjects 18-65 years of old, inclusive

- Documented chronic HCV infection to be of at least 6 months duration and plasma HCV
RNA ≥ 5 log10 IU/mL at screening.

- HCV treatment naïve or PEG-IFN, IFN, and/or RBV experienced (treatment must have
ceased at least 3 months prior to screening). Treatment experienced subjects should
not exceed 40% of the subjects enrolled in each cohort

- Mono-infection with HCV genotype 1a for Cohorts 1, 2, 3, 4, and 5 and mono-infection
with HCV genotype 1b for Cohort 6 and 7.

- Estimated creatinine clearance ≥ 70 mL/min,

- QTcF interval ≤ 450 msec for males and ≤ 470 msec for females, QRS duration < 120
msec, PR interval < 220 msec,

- Body mass index (BMI) of 19.0 to 34.0 kg/m^2, inclusive.

Exclusion Criteria:

- Urine drug screen positive for illicit/illegal drugs

- ALT and AST levels > 5 times the upper limit of the normal range (ULN)

- Direct bilirubin > ULN, clinical or other laboratory evidence of hepatic
decompensation (i.e., platelets < 90,000/mm^3, prothrombin time ≥ 1.5 × ULN and
albumin < 3.5 g/dL) are not eligible for study participation.

- Subjects with an absolute neutrophil count (ANC) < 1,000 cells/mm^3 (< 750 cells/mm^3
for black or African-American subjects), hemoglobin (Hb) < 11 g/dL,

- Coinfected with hepatitis B virus (HBV), human immunodeficiency virus (HIV), or
another HCV genotype other than genotype 1a/b are not eligible for study
participation.

- Evidence of hepatocellular carcinoma (e.g., a-fetoprotein > 50 ng/mL or as indicated
by recent ultrasound or other standard of care measure)

- History of significant cardiac disease. The following ECG abnormalities at screening
are exclusionary: QTcF (QT corrected using Fridericia's formula=QT/RR^0.333) > 450
msec for males and > 470 for females; QRS > 120 msec (left or right hemiblock is not
exclusionary); PR interval > 220 msec; bradycardia (< 45 beats per minute); second or
third degree heart block.

- History of clinically-significant illness or any other major medical disorder that may
interfere with subject treatment, assessment or compliance with the protocol

- History of a primary gastrointestinal disorder that could interfere with the
absorption of the study drug or that could interfere with normal gastrointestinal
anatomy or motility