A Single Ascending Dose Study of BMS-650032 in HCV Infected Subjects
Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-650032 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1
1 other identifier
interventional
24
1 country
5
Brief Summary
The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-650032 in subjects with chronic hepatitis C infection
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2008
Shorter than P25 for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2007
CompletedFirst Posted
Study publicly available on registry
November 16, 2007
CompletedStudy Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedSeptember 13, 2010
September 1, 2010
6 months
November 15, 2007
September 10, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Safety Outcome Measures
Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose
Secondary Outcomes (2)
Pharmacokinetic Measures
Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose
Pharmacodynamic Measures
Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing
Study Arms (4)
or Placebo - Dose Panel 1
EXPERIMENTALOral Suspension, 10 mg
or Placebo - Dose Panel 2
EXPERIMENTALOral Suspension 50 mg
or Placebo - Dose Panel 3
EXPERIMENTALOral Suspension, 200 mg
or Placebo - Dose Panel 4
EXPERIMENTALOral Suspension or Solution, 2.5 to 600 mg
Interventions
Oral, Once daily, Single Dose
Eligibility Criteria
You may qualify if:
- Chronically infected with HCV genotype 1
- Treatment naive or treatment non-responders or treatment intolerant
- HCV RNA viral load of ≥10\*5 IU/mL
- BMI 18 to 35kg/m²
You may not qualify if:
- Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
- Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
- Co-infection with HIV or HBV
- Women of childbearing potential
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
West Coast Clinical Trials, Llc
Cypress, California, 90630, United States
Orlando Clinical Research Center
Orlando, Florida, 32809, United States
Parexel International Corporation
Baltimore, Maryland, 21225, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 15, 2007
First Posted
November 16, 2007
Study Start
January 1, 2008
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
September 13, 2010
Record last verified: 2010-09