Multiple Ascending Dose Study of BMS-929075 in Hepatitis C Virus (HCV) Infected Patients

• Status: Withdrawn
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: 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 subjects

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• 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