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Lead
Bristol-Myers Squibb
Primary Purpose: Other: This Phase 1 study is a clinical pharmacology thorough QT study.
Age
18–49
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Healthy men and women, ages 18 to 49 yr old
BMI 18 to 32
Women must not be pregnant or breastfeeding
You may not be 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
Clareo Health | Study to Determine the Effect of BMS-791325 on the ECG QTcF Interval in Healthy Subjects
