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

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 1

Conditions: Chronic Hepatitis C

Treatments: Drug: BMS-929075; Drug: Placebo matching BMS-929075

Study type: Interventional

Funder types: Industry

Identifiers

NCT01525212

AI457-002

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups

Arm 1: BMS-929075 (≤ 25 mg) OR Placebo matching BMS-929075

Experimental group

Treatment:

Drug: Placebo matching BMS-929075

Drug: BMS-929075

Arm 2: BMS-929075 (≤ 100 mg) OR Placebo matching BMS-929075

Experimental group

Treatment:

Drug: Placebo matching BMS-929075

Drug: BMS-929075

Arm 3: BMS-929075 (≤ 400 mg) OR Placebo matching BMS-929075

Experimental group

Treatment:

Drug: Placebo matching BMS-929075

Drug: BMS-929075

Arm 4: BMS-929075 (≤ 800 mg) OR Placebo matching BMS-929075

Experimental group

Treatment:

Drug: Placebo matching BMS-929075

Drug: BMS-929075