A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects
NCT ID: NCT00663208
Last Updated: 2015-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
167 participants
INTERVENTIONAL
2008-05-31
2009-06-30
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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Group 1
Daclatasvir (1 mg), once daily
or
Matching Placebo, once daily
Daclatasvir
Capsule, Oral, Approximately 182 days from initial dosing
Placebo
Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
Group 2
Daclatasvir (10 mg), once daily
or
Matching Placebo, once daily
Daclatasvir
Capsule, Oral, Approximately 182 days from initial dosing
Placebo
Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
Group 3
Daclatasvir (1-100 mg), once or twice daily
or
Matching Placebo, once or twice daily
Daclatasvir
Capsule, Oral, Approximately 182 days from initial dosing
Placebo
Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
Group 4
Daclatasvir (1-100 mg), once or twice daily
or
Matching Placebo, once or twice daily
Daclatasvir
Capsule, Oral, Approximately 182 days from initial dosing
Placebo
Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
Group 5
Group 5: Active Comparator
Daclatasvir (1-100 mg), once or twice daily
or
Matching Placebo, once or twice daily
Daclatasvir
Capsule, Oral, Approximately 182 days from initial dosing
Placebo
Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
Group 6
Group 6: Active Comparator
Daclatasvir (1-100 mg), once or twice daily
or
Matching Placebo, once or twice daily
Daclatasvir
Capsule, Oral, Approximately 182 days from initial dosing
Placebo
Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
Interventions
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Daclatasvir
Capsule, Oral, Approximately 182 days from initial dosing
Placebo
Capsule, Oral, After 28 days from initial dosing and unblinding of the dose panel
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
* HCV RNA viral load of ≥10\*5 IU/mL
* BMI 18 to 35kg/m²
Exclusion Criteria
* HIV and/or HBV positive
* Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug
WOCBP will be enrolled as in-patient for 16 days
18 Years
60 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 Res Inst
Anaheim, California, United States
West Coast Clinical Trials, Llc
Cypress, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Elite Research Institute
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Parexel International Corporation
Baltimore, Maryland, United States
Alamo Medical Research
San Antonio, Texas, United States
Local Institution
Santurce, , Puerto Rico
Countries
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References
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Nettles RE, Gao M, Bifano M, Chung E, Persson A, Marbury TC, Goldwater R, DeMicco MP, Rodriguez-Torres M, Vutikullird A, Fuentes E, Lawitz E, Lopez-Talavera JC, Grasela DM. Multiple ascending dose study of BMS-790052, a nonstructural protein 5A replication complex inhibitor, in patients infected with hepatitis C virus genotype 1. Hepatology. 2011 Dec;54(6):1956-65. doi: 10.1002/hep.24609.
Related Links
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Investigator Inquiry form
Other Identifiers
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AI444-004
Identifier Type: -
Identifier Source: org_study_id
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