Study to Determine the Effect of BMS-791325 on the ECG QTcF Interval in Healthy Subjects
NCT ID: NCT02084953
Last Updated: 2014-07-28
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
59 participants
INTERVENTIONAL
2014-04-30
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
QUADRUPLE
Study Groups
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ARM A: BMS-791325
BMS-791325 600 mg tablet orally on 1st and 2nd day, then 900 mg on the 3rd day once a day for 3 days
BMS-791325
ARM B: Moxifloxacin
Moxifloxacin 400mg tablet orally once on third day
Moxifloxacin
ARM C: Placebo matching BMS-791325
Placebo matching BMS-791325 0 mg tablet orally once daily for 3 days
Placebo matching BMS-791325
Interventions
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BMS-791325
Moxifloxacin
Placebo matching BMS-791325
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI 18 to 32
* Women must not be pregnant or breastfeeding
Exclusion Criteria
* A personal history of clinically relevant cardiac disease, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
* History of hypokalemia, personal history or family history of prolonged QT interval, or family history of sudden cardiac death at a young age
* History of biliary disorders, including Gilbert's disease or Dubin-Johnson disease
* Inability to swallow multiple tablets consecutively
* Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration: PR ≥ 210 msec, QRS ≥ 120 msec, QT ≥ 500 msec, QTcF ≥ 450 msec, Heart Rate (HR) \< 45 bpm
* Second or third degree heart block prior to study drug
* Positive urine screen for drugs of abuse
* Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, or Human Immunodeficiency Virus (HIV)-1, -2 antibody
* Any of the following lab results outside of the ranges specified below prior to dosing: Alanine aminotransferase (ALT) \> upper limit of normal (ULN), Aspartate aminotransferase (AST) \> ULN, Total bilirubin \> ULN, Direct bilirubin \> ULN, Creatinine \> ULN, Serum potassium \< lower limit of normal (LLN), Serum magnesium \< LLN
* History of allergy to Moxifloxacin, BMS-791325, nonstructural protein 5B (NS5B) non-nucleoside inhibitors or related compounds
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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Ppd Development, Llc
Austin, 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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AI443-112
Identifier Type: -
Identifier Source: org_study_id
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