Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325
NCT ID: NCT02095860
Last Updated: 2014-10-10
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
24 participants
INTERVENTIONAL
2014-04-30
2014-05-31
Brief Summary
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Detailed Description
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Primary Purpose:
Other: Phase 1 clinical pharmacology bioavailability study to assess food effect
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Treatment A: DCV 3DAA FDC fasted state
DCV 3 Direct Acting Antiviral (DAA) Fixed Dose Combination (FDC) tablet by mouth once on specified days in fasted state
DCV 3DAA FDC
Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325
Treatment B: DCV 3DAA FDC with high-fat meal
DCV 3DAA FDC tablet by mouth once on specified days with high-fat meal
DCV 3DAA FDC
Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325
Treatment C: DCV 3DAA FDC with light meal
DCV 3DAA FDC tablet by mouth once on specified days with light meal
DCV 3DAA FDC
Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325
Interventions
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DCV 3DAA FDC
Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325
Eligibility Criteria
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Inclusion Criteria
* Women of childbearing potential must be using an acceptable method of contraception for at least 4 weeks prior to study drug administration.
Exclusion Criteria
* Current or recent (within 3 months of study drug administration) gastrointestinal disease
* Any gastrointestinal surgery that could impact upon the absorption of study drug, including cholecystectomy
* History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease
* Use of tobacco-containing or nicotine-containing products
* Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration, confirmed by repeat:
* PR ≥210 msec
* QRS ≥120 msec
* QT ≥500 msec
* QTcF ≥450 msec
* Any of the following laboratory results outside of the ranges specified below prior to study drug administration, confirmed by repeat:
* Alanine aminotransferase (ALT) \>Upper limit of normal (ULN)
* Aspartate aminotransferase (AST) \>ULN
* Total bilirubin (TBILI) \>ULN
* Creatinine \>ULN
18 Years
49 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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Healthcare Discoveries, Llc D/B/A Icon Development Solutions
San Antonio, Texas, 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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AI443-111
Identifier Type: -
Identifier Source: org_study_id
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