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Lead
Bristol-Myers Squibb
CYP = Cytochrome p-450
Primary Purpose: Other: This is a Phase 1 clinical pharmacology thorough QT study being conducted as a post marketing requirement
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 volunteers, ages 18 to 49 years old
BMI 18 to 32 kg/m2
Women must not be pregnant or breastfeeding
You may not be if
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
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, 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, Efavirenz or related compounds
Clareo Health | Study to Determine the Effect of Efavirenz on the ECG QTcF Interval in Healthy Subjects
