Status:
WITHDRAWN
Multiple Ascending Dose Study of BMS-929075 in Hepatitis C Virus (HCV) Infected Patients
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01525212
Start Date
April 1 2012
End Date
February 1 2013
Last Update
June 21 2013
Active Locations (3)
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1
Local Institution
Herston, Queensland, Australia, 4006
2
Local Institution
Adelaide, South Australia, Australia, 5000
3
Local Institution
Melbourne, Victoria, Australia, 3004