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Clinical Trials

MainTitle

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

This study has been completed
Sponsor
Bristol-Myers Squibb


Information provided by (Responsible Party)
Bristol-Myers Squibb
ClinicalTrials.gov Identifier
NCT02164812

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

Purpose

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
HIV/AIDS

Drug : Moxifloxacin
Drug : Placebo
Drug : Efavirenz
Phase 1

Study Type: Interventional
Study Design: 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

Eligibility

Eligibility

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

Criteria

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

contacts and locations

Contacts and Locations

Choosing to participate in a study is an important personal decision.Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02164812

Locations

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

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

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

More Information

Additional Information:

BMS Clinical Trial Information

Additional Information:

BMS clinical trial educational resource

Additional Information:

Investigator Inquiry form

Additional Information:

FDA Safety Alerts and Recalls

Responsible Party: Bristol-Myers Squibb  
ClinicalTrials.gov 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:
Moxifloxacin
Fluoroquinolones
Efavirenz
Norgestimate, ethinyl estradiol drug combination

ClinicalTrials.gov processed this data on October 23, 2017
This information is provided by ClinicalTrials.gov.