A Phase 1 interventional study of Moxifloxacin and Placebo in HIV/AIDS, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-09-07.
Sponsored by Bristol-Myers Squibb · Phase 1 and Interventional
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
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 58 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
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Inclusion Criteria:
Exclusion Criteria:
Moxifloxacin, Placebo, Efavirenz single dose as specified
Drug: Moxifloxacin · Drug: Placebo · Drug: Efavirenz
Also known as: Avelox®
Also known as: Sustiva®, BMS-561525
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
Serious AE (SAE)
Time frame: Up to 30 days after discontinuation of dose (approximately 52 days)
This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Bristol-Myers Squibb