A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects
NCT ID: NCT00546715
Last Updated: 2015-11-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
95 participants
INTERVENTIONAL
2007-11-30
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dose Panel A
Daclatasvir - 1 mg
Placebo - 0 mg
Daclatasvir
Oral Solution, Oral, Single Dose
Placebo
Oral Solution, Oral, Single Dose
Dose Panel B
Daclatasvir - 10 mg
Placebo - 0 mg
Daclatasvir
Oral Solution, Oral, Single Dose
Placebo
Oral Solution, Oral, Single Dose
Dose Panel C
Daclatasvir - 100 mg
Placebo - 0 mg
Daclatasvir
Oral Solution, Oral, Single Dose
Placebo
Oral Solution, Oral, Single Dose
Dose Panel D
Daclatasvir - 0.5 - 200 mg (to be determined)
Placebo - 0 mg
Daclatasvir
Oral Solution, Oral, Single Dose
Placebo
Oral Solution, Oral, Single Dose
Interventions
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Daclatasvir
Oral Solution, Oral, Single Dose
Placebo
Oral Solution, Oral, Single Dose
Eligibility Criteria
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Inclusion Criteria
* Treatment naive or treatment non-responders or treatment intolerant; and not co-infected with HIV or hepatitis B virus
* Hepatitis C virus RNA viral load of ≥ 10\*5\* IU/mL
* BMI 18 to 35 kg/m²
Exclusion Criteria
* Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
18 Years
49 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Advanced Clinical Research Institute
Anaheim, California, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Parexel International Corporation
Baltimore, Maryland, United States
Mayo Clinic
Rochester, Minnesota, United States
Bristol-Myers Squibb Clinical Pharmacology Unit
Hamilton, New Jersey, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
University Of Virginia Digestive Health Center Of Excellence
Charlottesville, Virginia, United States
Countries
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Other Identifiers
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AI444-002
Identifier Type: -
Identifier Source: org_study_id