Status:
COMPLETED
Safety, Tolerability, Pharmacokinetics and Antiviral Activity of GS-9669 in Subjects With Chronic Hepatitis C Virus Infection
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a research study to evaluate the safety, tolerability and anti-viral activity of GS-9669 in patients with Hepatitis C infection.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01431898
Start Date
September 1 2011
End Date
May 1 2012
Last Update
July 25 2012
Active Locations (11)
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1
Impact Clinical Trials
Los Angeles, California, United States, 90036
2
Avail Clinical Research, LLC
DeLand, Florida, United States, 32720
3
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
4
Impact Clinical Trials
Las Vegas, Nevada, United States, 89106