To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet
NCT ID: NCT02108639
Last Updated: 2014-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
41 participants
INTERVENTIONAL
2014-04-30
2014-06-30
Brief Summary
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Detailed Description
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Primary Purpose: Other - Phase 1 Clinical Pharmacology study to determine the effect of renal impairment on the exposure of DCV, ASV, BMS-791325 (fixed dosed combination) and BMS-791325 given in multiple doses
Fixed dose combination (FDC)
Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325 (DCV 3DAA FDC)
Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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DCV 3DAA FDC + BMS-791325
Group A to D: DCV 3DAA FDC + BMS-791325 oral tablets on specific days
Group E: DCV 3DAA FDC + BMS-791325 oral tablets on specific days
DCV 3DAA FDC
BMS-791325
Interventions
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DCV 3DAA FDC
BMS-791325
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects in Groups B-E may have clinical, Electrocardiogram (ECG) and laboratory findings consistent with their degree of renal dysfunction
* Women of childbearing potential (WOCBP) and male participants must agree to follow the required contraceptive methods
Exclusion Criteria
* Subjects in Groups B-E must not have uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, and/or neurological disease within 6 months of screening
* Subjects in Groups B-E may not have evidence of rapidly deteriorating renal function, defined as a screening creatinine clearance (CLcr) which has decreased from a previous CLcr by 50% within the last 3 months
* Prior exposure to DCV, ASV or BMS-791325 within 3 months prior to study drug administration
18 Years
ALL
Yes
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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Clinical Pharmacology Of Miami Inc.
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Davita Clinical Research
Minneapolis, Minnesota, United States
New Orleans Center For Clinical Research - Knoxville
Knoxville, Tennessee, United States
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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AI443-110
Identifier Type: -
Identifier Source: org_study_id
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