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

NCT01525212 | Withdrawn Phase 1

• 1 other identifier: AI457-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

• HCV RNA level on Day 4

  Within 4 days after the first dose

Secondary Outcomes (12)

• Maximum decrease from baseline in plasma HCV RNA levels during the period from Day 1 to Day 28

  Days 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 28

  Days 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 tests

  Days 1-28 (with SAE from screening to Day 30)

• Maximum observed plasma concentration (Cmax) of BMS-929075 derived from plasma concentration versus time

  Day 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 time

  Day 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)

Study Arms (4)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

BMS-929075 DRUG

Oral Suspension, ≤ 25 mg, Once daily, 3 days

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

Placebo matching BMS-929075 DRUG

Oral Suspension, 0 mg, Once daily, 3 days

Arm 1: BMS-929075 (≤ 25 mg) OR Placebo matching BMS-929075; Arm 2: BMS-929075 (≤ 100 mg) OR Placebo matching BMS-929075; Arm 3: BMS-929075 (≤ 400 mg) OR Placebo matching BMS-929075

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (3)

Local Institution

Herston, Queensland, 4006, Australia

Location

Local Institution

Adelaide, South Australia, 5000, Australia

Location

Local Institution

Melbourne, Victoria, 3004, Australia

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2012
• First Posted: February 2, 2012
• Study Start: April 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 21, 2013

Record last verified: 2013-06

Locations

AU (3)