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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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CYP = Cytochrome p-450

Primary Purpose: Other: This is a Phase 1 clinical pharmacology thorough QT study being conducted as a post marketing requirement

Conditions

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HIV/AIDS

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Moxifloxacin, Placebo, Efavirenz

Moxifloxacin, Placebo, Efavirenz single dose as specified

Group Type EXPERIMENTAL

Moxifloxacin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Efavirenz

Intervention Type DRUG

Interventions

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Moxifloxacin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Efavirenz

Intervention Type DRUG

Other Intervention Names

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Avelox® Sustiva® BMS-561525

Eligibility Criteria

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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 \<lower limit of normal (LLN), Serum magnesium \<LLN
* History of allergy to Moxifloxacin, Efavirenz or related compounds

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes