Study to Determine the Effect of Efavirenz on the ECG QTcF Interval in Healthy Subjects

Completed · Phase 1 · Has a placebo group

Conditions studied: HIV/AIDS

In brief

The purpose of this study is to determine whether multiple doses of Efavirenz has an effect on the QTc interval (corrected by Fridericia) in CYP2B6 \*1/\*6 and \*6/\*6 healthy subjects.

Key facts

Study ID

NCT02164812

Run by

Bristol-Myers Squibb

People needed

58

Starts

2014-07-01

Expected to finish

2015-08-01

Last updated by the study team

2015-09-07

Who can join

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

You may qualify if…

• Healthy volunteers, ages 18 to 49 years old
• BMI 18 to 32 kg/m2
• Women must not be pregnant or breastfeeding

You may not qualify 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

Where it is running

• Parexel International - Baltimore Epcu — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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