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.
CYP = Cytochrome p-450 Primary Purpose: Other: This is a Phase 1 clinical pharmacology thorough QT study being conducted as a post marketing requirement
Study Type
INTERVENTIONAL
Allocation
NA
Masking
NONE
Enrollment
58
Parexel International - Baltimore Epcu
Baltimore, Maryland, United States
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)
QTcF = QT corrected for Fridericia's formula
Time frame: Days 1, 2, 5, 6, 19 and 20
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
ECG = Electrocardiogram
Time frame: Days 1, 5 and 19
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
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Serious AE (SAE)
Time frame: Up to 30 days after discontinuation of dose (approximately 52 days)