Clinical Trials


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

This study has been completed
Bristol-Myers Squibb

Information provided by (Responsible Party)
Bristol-Myers Squibb Identifier

First received: June 13, 2014
Last updated: September 3, 2015
Last Verified: September 2015
History of Changes


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.

Condition Intervention Phase

Drug : Moxifloxacin
Drug : Placebo
Drug : Efavirenz
Phase 1

Study Type: Interventional
Study Design: Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Study to Determine the Concentration-Electrocardiographic Effects of Efavirenz in Healthy Subjects Enriched for CYP2B6 Polymorphisms

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures

  • Difference from placebo of Efavirenz (EFV) in change from period-specific baseline in the QT interval corrected for heart rate (HR) via Fridericia's method (QTcF) at postdose extraction times (ΔΔQTcF) [ Time Frame: Days 1, 2, 5, 6, 19 and 20 ]
    QTcF = QT corrected for Fridericia's formula
Secondary Outcome Measures:
  • Difference from placebo of EFV in change from period-specific baseline in other ECG parameters: HR, PR, QRS, and uncorrected QT following 14 days of dosing [ Time Frame: Days 1, 5 and 19 ]
    ECG = Electrocardiogram
  • Difference from placebo of Moxifloxacin in change from period-specific baseline in QTcF (ΔΔQTcF) following a single dose [ Time Frame: Days 1, 5 and 19 ]
  • Number and percent of subjects having a maximum QTcF, HR, PR, and QRS outside of pre-specified categories and those having a maximum ΔQTcF outside of pre-specified categories [ Time Frame: Days 1, 5 and 19 ]
  • Time of maximum observed plasma concentration (Tmax) of EFV [ Time Frame: Days 1, 2, 19 and 20 ]
  • Maximum observed plasma concentration (Cmax) of EFV [ Time Frame: Days 1, 2, 19 and 20 ]
  • Trough observed plasma concentration 24 h after a dose (C24) of EFV [ Time Frame: Days 1, 2, 19 and 20 ]
  • Area under the concentration-time curve in one dosing interval (AUC(TAU)) of EFV [ Time Frame: Days 1, 2, 19 and 20 ]
  • Safety based on incidence of AEs, SAEs, AEs leading to discontinuation, marked laboratory abnormalities, findings on 12-lead safety ECG measurements and physical examinations, and abnormalities in vital sign measurements exceeding pre-defined thresholds [ Time Frame: Up to 30 days after discontinuation of dose (approximately 52 days) ]
    Serious AE (SAE)

Enrollment: 58
Study Start Date: July 2014
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Experimental: Moxifloxacin, Placebo, Efavirenz
Moxifloxacin, Placebo, Efavirenz single dose as specified
Drug: Moxifloxacin
Other Name: Avelox®
Drug: Placebo
Drug: Efavirenz
Other Name:
  • Sustiva®
  • BMS-561525

Detailed Description:

CYP = Cytochrome p-450
Primary Purpose: Other: This is a Phase 1 clinical pharmacology thorough QT study being conducted as a post marketing requirement



Ages Eligible for Study: 18 Years to 49 Years  
Sexes Eligible for Study: All  
Accepts Healthy Volunteers: Yes  


For more information regarding BMS clinical trial participation, please visit
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

contacts and locations

Contacts and Locations

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Please refer to this study by its identifier: NCT02164812


United States, Maryland
Parexel International - Baltimore Epcu
Baltimore, Maryland, United States, 21225

Sponsors and Collaborators

Bristol-Myers Squibb


Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information

More Information

Additional Information:

BMS clinical trial educational resource

Additional Information:

Investigator Inquiry form

Responsible Party: Bristol-Myers Squibb Identifier: NCT02164812   History of Changes  
Other Study ID Numbers: AI266-959  
Study First Received: June 13, 2014  
Last Updated: September 3, 2015  

Additional relevant MeSH terms:
Efavirenz processed this data on May 29, 2020
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