Study to Determine the Effect of BMS-791325 on the ECG QTcF Interval in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: Hepatitis C

In brief

The purpose of this study is to determine whether BMS-791325 has an effect on the electrocardiogram (ECG) interval QT corrected for Fridericia's method (QTcF).

Key facts

Study ID

NCT02084953

Run by

Bristol-Myers Squibb

People needed

59

Starts

2014-04-01

Expected to finish

2014-05-01

Last updated by the study team

2014-07-28

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy men and women, ages 18 to 49 yr old
• BMI 18 to 32
• Women must not be pregnant or breastfeeding

You may not qualify if…

• Any significant acute or chronic medical illness
• 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

Where it is running

• Ppd Development, Llc — Austin, Texas, United States

Full record on ClinicalTrials.gov

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