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

Phase 1
Withdrawn
Conditions
Chronic Hepatitis C
Interventions
Drug: BMS-929075
Drug: Placebo matching BMS-929075
Registration Number
NCT01525212
Lead Sponsor
Bristol-Myers Squibb
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 infected subjects

Detailed Description

Not available

Recruitment & Eligibility

Status
WITHDRAWN
Sex
All
Target Recruitment
Not specified
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm 4: BMS-929075 (≤ 800 mg) OR Placebo matching BMS-929075BMS-929075-
Arm 1: BMS-929075 (≤ 25 mg) OR Placebo matching BMS-929075Placebo matching BMS-929075-
Arm 2: BMS-929075 (≤ 100 mg) OR Placebo matching BMS-929075Placebo matching BMS-929075-
Arm 3: BMS-929075 (≤ 400 mg) OR Placebo matching BMS-929075Placebo matching BMS-929075-
Arm 4: BMS-929075 (≤ 800 mg) OR Placebo matching BMS-929075Placebo matching BMS-929075-
Arm 1: BMS-929075 (≤ 25 mg) OR Placebo matching BMS-929075BMS-929075-
Arm 2: BMS-929075 (≤ 100 mg) OR Placebo matching BMS-929075BMS-929075-
Arm 3: BMS-929075 (≤ 400 mg) OR Placebo matching BMS-929075BMS-929075-
Primary Outcome Measures
NameTimeMethod
HCV RNA level on Day 4Within 4 days after the first dose
Secondary Outcome Measures
NameTimeMethod
Maximum decrease from baseline in plasma HCV RNA levels during the period from Day 1 to Day 28Days 1-28
Time course of the change from baseline in plasma HCV RNA levels and the time of maximum decrease during the period of Day 1 through Day 28Days 1-28
Safety assessments will be based on medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory testsDays 1-28 (with SAE from screening to Day 30)
Maximum observed plasma concentration (Cmax) of BMS-929075 derived from plasma concentration versus timeDay 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Minimum observed plasma concentration (Cmin) of BMS-929075 derived from plasma concentration versus timeDay 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Trough observed plasma concentration (Ctrough) of BMS-929075 derived from plasma concentration versus timeDay 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Time of maximum observed plasma concentration (Tmax) of BMS-929075 derived from plasma concentration versus timeDay 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Area under the concentration-time curve in one dosing interval [AUC(TAU)] of BMS-929075 derived from plasma concentration versus timeDay 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Plasma half-life (T-HALF) of BMS-929075 derived from plasma concentration versus timeDay 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
Protein Binding (PB) of BMS-929075 derived from plasma concentration versus timeDay 3 (0h and 2h)
Fraction of free drug in plasma (fu) of BMS-929075 derived from plasma concentration versus timeDay 1 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h), Day 2, and Day 3 (0h, 0.5h, 1 h, 1.5h, 2h, 3h, 4h, 6h, 8h, 12h,24h, 36h, 48h and 72h)
The relationship between antiviral activity and measures of exposure to BMS-929075Days 1-6

Trial Locations

Locations (1)

Local Institution

🇦🇺

Melbourne, Victoria, Australia

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