Multiple Ascending Dose Study of BMS-929075 in Hepatitis C Virus (HCV) Infected Patients
NCT ID: NCT01525212
Last Updated: 2013-06-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2012-04-30
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1: BMS-929075 (≤ 25 mg) OR Placebo matching BMS-929075
BMS-929075
Oral Suspension, ≤ 25 mg, Once daily, 3 days
Placebo matching BMS-929075
Oral Suspension, 0 mg, Once daily, 3 days
Arm 2: BMS-929075 (≤ 100 mg) OR Placebo matching BMS-929075
BMS-929075
Oral Suspension, ≤ 100 mg, Once daily, 3 days
Placebo matching BMS-929075
Oral Suspension, 0 mg, Once daily, 3 days
Arm 3: BMS-929075 (≤ 400 mg) OR Placebo matching BMS-929075
BMS-929075
Oral Suspension, ≤ 400 mg, Once daily, 3 days
Placebo matching BMS-929075
Oral Suspension, 0 mg, Once daily, 3 days
Arm 4: BMS-929075 (≤ 800 mg) OR Placebo matching BMS-929075
BMS-929075
Oral Suspension, (≤ 800 mg, Once daily) OR (≤ 400 mg, Twice daily), 3 days
Placebo matching BMS-929075
Oral Suspension, 0 mg, (Once daily for ≤ 800 mg group) OR (Twice daily for ≤ 400 mg group), 3 days
Interventions
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BMS-929075
Oral Suspension, ≤ 25 mg, Once daily, 3 days
BMS-929075
Oral Suspension, ≤ 100 mg, Once daily, 3 days
BMS-929075
Oral Suspension, ≤ 400 mg, Once daily, 3 days
BMS-929075
Oral Suspension, (≤ 800 mg, Once daily) OR (≤ 400 mg, Twice daily), 3 days
Placebo matching BMS-929075
Oral Suspension, 0 mg, Once daily, 3 days
Placebo matching BMS-929075
Oral Suspension, 0 mg, (Once daily for ≤ 800 mg group) OR (Twice daily for ≤ 400 mg group), 3 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Herston, Queensland, Australia
Local Institution
Adelaide, South Australia, Australia
Local Institution
Melbourne, Victoria, Australia
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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AI457-002
Identifier Type: -
Identifier Source: org_study_id
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