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

Completed · Phase 1 · Has a placebo group

Conditions studied: Hepatitis C

In brief

This is a research study to evaluate the safety, tolerability and anti-viral activity of GS-9669 in patients with Hepatitis C infection.

Key facts

Study ID

NCT01431898

Run by

Gilead Sciences

People needed

82

Starts

2011-09-01

Expected to finish

2012-05-01

Last updated by the study team

2012-07-25

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Impact Clinical Trials — Los Angeles, California, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• Impact Clinical Trials — Las Vegas, Nevada, United States
• CRI Worldwide — Willingboro, New Jersey, United States
• CRI Worldwide — Philadelphia, Pennsylvania, United States
• Alamo Medical Research — San Antonio, Texas, United States
• Lifetree Clinical Research, LC — Salt Lake City, Utah, United States
• University of Utah Health Sciences Center — Salt Lake City, Utah, United States
• Charles River Clinical Services Northwest — Tacoma, Washington, United States
• Fundacion de Investigacion de Diego — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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