Overview

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Withdrawn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