Study to Determine the Effect of Efavirenz on the ECG QTcF Interval in Healthy Subjects
Status: | Completed |
---|---|
Conditions: | HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 49 |
Updated: | 4/21/2016 |
Start Date: | July 2014 |
End Date: | August 2015 |
A Study to Determine the Concentration-Electrocardiographic Effects of Efavirenz in Healthy Subjects Enriched for CYP2B6 Polymorphisms
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.
on the QTc interval (corrected by Fridericia) in CYP2B6 *1/*6 and *6/*6 healthy subjects.
CYP = Cytochrome p-450
Primary Purpose: Other: This is a Phase 1 clinical pharmacology thorough QT study being
conducted as a post marketing requirement
Primary Purpose: Other: This is a Phase 1 clinical pharmacology thorough QT study being
conducted as a post marketing requirement
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com
Inclusion Criteria:
- Healthy volunteers, ages 18 to 49 years old
- BMI 18 to 32 kg/m2
- 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
- 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
- History of allergy to Moxifloxacin, Efavirenz or related compounds
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