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

Bristol-Myers Squibb (BMS) logo

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Withdrawn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

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

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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