Overview
Multiple Ascending Dose Study of BMS-929075 in Hepatitis C Virus (HCV) Infected Patients
Status:
Withdrawn
Withdrawn
Trial end date:
2013-02-01
2013-02-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to determine the change from baseline in HCV Ribonucleic acid (RNA) on Day 4 following three days of dosing with BMS-929075 in chronically genotype subtype 1a and 1b HCV infected subjectsPhase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Bristol-Myers Squibb
Criteria
Inclusion Criteria:- Men and women, ages 18 to 65 years, inclusive
- Subjects who are naive to HCV treatment, defined as no previous exposure to an
Interferon (IFN), Ribavirin (RBV); or any HCV-specific direct acting antiviral or
experimental therapy
- HCV genotype 1a or 1b only
- HCV RNA viral load of ≥ 100,000 IU/mL
- Have one of the following: i) Documented Fibrotest score of ≤ 0.72 and AST to platelet
ratio index (APRI) ≤ 2; or ii) Documented liver biopsy within 12 months preceding Day
1 showing absence of cirrhosis
- Body Mass Index (BMI) of 18.0 to 35.0 kg/m2, inclusive
Exclusion Criteria:
- Any significant acute or chronic medical illness
- History of adrenal gland disease, including but not limited to adrenal insufficiency
or Cushing's syndrome
- Current or recent (within 3 months of study drug administration) gastrointestinal
disease
- Any major surgery within 4 weeks of study drug administration
- Any gastrointestinal surgery that could impact upon the absorption of study drug
- Positive for hepatitis B surface antigen (HBsAg)
- Positive for Human Immunodeficiency Virus (HIV) -1 and/or -2 antibodies
- Smoking > 10 cigarettes per day
- Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) > 5x upper limit of
normal (ULN)
- Total Bilirubin ≥ 1.5x ULN
- Hemoglobin < 10 g/dL
- Platelets < 75,000 cell/μL
- ALC (absolute lymphocyte count) < 1000 cell/μL
- Creatinine clearance (as estimated by method of Cockcroft and Gault) less than 60
mL/min