A Phase 1 interventional study of GSK1265744 and GSK1265744 matching placebo in Infection, Human Immunodeficiency Virus, sponsored by ViiV Healthcare. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-06-16.
Sponsored by ViiV Healthcare · Phase 1, Interventional, and Treatment
This study is being conducted to comply with the Food and Drug Administration (FDA) recommendation that all new non anti-arrhythmic drugs be assessed for cardiac repolarization effects through electrocardiographic evaluation. Therefore, this study will evaluate the effect of GSK1265744 on cardiac conduction as assessed by collection of twelve-lead continuous digital data in healthy adults. This study will evaluate the effect of three doses of GSK1265744 on the QT duration corrected for heart rate (QTc) interval as compared to placebo. Moxifloxacin will be used as a positive control in order to validate the sensitivity of the study in detecting QTc change. This study consists of three treatment periods (each separated by 21 day washout period) followed by follow-up visit 10 to 14 days post last dosing. The total duration of study including follow-up visit will be approximately 62 days. Approximately 42 subjects will be enrolled such that 34 subjects complete dosing and critical assessments.
2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.
This study's enrollment of 42 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.
Browse Acquired Immunodeficiency Syndrome studies →ViiV Healthcare is the lead sponsor of 261 studies on the registry; 16 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 50 (76%) have results posted.
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Exclusion Criteria
Evidence of previous myocardial infarction (Does not include ST segment changes associated with repolarization).
Any conduction abnormality (including but not specific to left or right complete bundle branch block, atrioventricular block [2nd degree or higher], Wolf Parkinson White syndrome).
Sinus Pauses > 3 seconds. Any significant arrhythmia which, in the opinion of the principal investigator and GSK medical monitor, will interfere with the safety for the individual subject.
Non-sustained or sustained ventricular tachycardia (>=3 consecutive ventricular ectopic beats).
Participants in this arm will receive treatment A in period 1, treatment B in period 2 and treatment C in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet).
Drug: GSK1265744 · Drug: GSK1265744 matching placebo · Drug: Moxifloxacin
Participants in this arm will receive treatment A in period 1, treatment C in period 2 and treatment B in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet).
Drug: GSK1265744 · Drug: GSK1265744 matching placebo · Drug: Moxifloxacin
Participants in this arm will receive treatment B in period 1, treatment A in period 2 and treatment C in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet).
Drug: GSK1265744 · Drug: GSK1265744 matching placebo · Drug: Moxifloxacin
Participants in this arm will receive treatment B in period 1, treatment C in period 2 and treatment A in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet).
Drug: GSK1265744 · Drug: GSK1265744 matching placebo · Drug: Moxifloxacin
Participants in this arm will receive treatment C in period 1, treatment A in period 2 and treatment B in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet).
Drug: GSK1265744 · Drug: GSK1265744 matching placebo · Drug: Moxifloxacin
Participants in this arm will receive treatment C in period 1, treatment B in period 2 and treatment A in period 3. Where treatment A= Three doses of GSK1265744 150 mg (5 x 30mg tablets) every 12 hours. B= Three doses of GSK1265744 placebo (5 tablets) every 12 hours. C= A single dose of Moxifloxacin 400mg (one 400mg tablet).
Drug: GSK1265744 · Drug: GSK1265744 matching placebo · Drug: Moxifloxacin
White to slightly colored film coated tablet with unit dose strength of 30 mg and dose level of 150mg (5 tablets of 3 mg) administered orally every 12hours for 3 doses.
GSK1265744 matching placebo tablets administered orally every 12hours for 3 doses (5 tablets per dose).
Dull red, oblong, convex film coated tablets with unit dose strength of 400 mg administered orally as a single dose.
Change from baseline in QT duration corrected for heart rate by Fridericia's formulas (QTcF) for GSK1265744
QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF interval will be obtained by digital electrocardiograms (ECG) obtained through 12 lead holter monitoring machine. Triplicate ECGs will be evaluated at each time point
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days)
Change from baseline in QT duration corrected for heart rate by Bazett's formula (QTcB), individual corrected QTc ( QTci) values, QT, QRS, and PR for GSK1265744
Single ECG will be obtained at all timepoints during the study using an ECG machine that automatically measures PR (beginning of P wave to the beginning of the next QRS), QRS (beginning of Q to the end of the S wave), QT, and QTc intervals.
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Change from baseline in heart rate (HR) for GSK1265744
Single ECGs will be obtained at all timepoints during the study using an ECG machine that automatically calculates the heart rate. Heart rate is defined as the number of heartbeats per unit of time, usually per minute.
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Change from baseline in QTcF, QTcB, QTci, QT, QRS, and PR for placebo
Single ECGs will be obtained at all timepoints during the study using an ECG machine that automatically calculates the QTcF, QTcB, QTCi, QT, QRS, PR intervals
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Change from baseline in HR for placebo
Single ECGs will be obtained at all timepoints during the study using an ECG machine that automatically calculates the heart rate. Heart rate is defined as the number of heartbeats per unit of time, usually per minute.
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Change from baseline in QTcF, QTcB, QTci, QT, QRS, and PR for Moxifloxacin
Single ECGs will be obtained at all timepoints during the study using an ECG machine that automatically calculates the QTcF, QTcB, QTCi, QT, QRS, PR intervals
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Change from baseline in HR for Moxifloxacin.
Single ECGs will be obtained at all timepoints during the study using an ECG machine that automatically calculates the heart rate. Heart rate is defined as the number of heartbeats per unit of time, usually per minute.
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Composite of pharmacokinetic (PK) parameters for GSK1265744.
PK parameters include: area under the concentration-time curve from time zero to last time of quantifiable concentration (AUC\[0-t\]), area under the concentration-time curve from time zero extrapolated to infinite time (AUC\[0-infinity\]), maximum observed concentration (Cmax), time of occurrence of Cmax (tmax), apparent clearance following oral dosing (CL/F), apparent volume of distribution at steady state after oral administration (Vdz/F), and terminal phase half-life (t1/2) from plasma concentrations of GSK1265744.
Time frame: Blood samples will be collected at following time points: Day 1 pre-dose (15 minutes prior to first dose 1), and at Day 2 pre-dose (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6.5, 8, 12, and 24 hours post last dose in each period.
Composite of PK parameters for Moxifloxacin (if needed).
PK parameters include: AUC (0-t), AUC (0-infinity), Cmax, tmax, CL/F, Vdz/f, and t1/2.
Time frame: Blood samples will be collected on Day 2 at pre-dose, 0.5, 1, 2, 3, 4, 6.5, 8, 12, and 24 hours post last dose in each period.
12-lead ECG as a measure of safety and tolerability.
12-lead ECGs will be performed with the subject in a semi-supine position having rested in this position for at least 10 minutes beforehand. ECGs will be obtained using an ECG machine that automatically calculates the QTcF, QTcB, QTCi, QT, QRS, PR intervals and HR.
Time frame: Up to 62 days.
Vital sign as a measure of safety and tolerability.
Vital sign measurement include: blood pressure and heart rate.
Time frame: Up to 62 days.
Number participants with adverse events as a measure of safety and tolerability.
AEs will be collected from the start of Study Treatment and until the follow-up contact.
Time frame: Up to 62 days.
Clinical laboratory parameters assessment as a measure of safety and tolerability.
Clinical laboratory assessment include: hematology, clinical chemistry, urinalysis and additional parameters as needed.
Time frame: Up to 62 days.
Change from baseline in QTcF, QTcB and QTci for GSK1265744
Single ECGs will be obtained at all timepoints during the study using an ECG machine that automatically calculates the QTcF, QTcB, and QTCi intervals.
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Difference between GSK1265744 and placebo in terms of change from baseline in QTcF, QTcB and QTci.
Difference between GSK12657744 and placebo in terms of change from baseline in QTcF, QTcB and QTci will be measured to characterize pharmacodynamic (PD) relationship between exposure of GSK1265744 and changes in QTcF, QTcB and QTci
Time frame: Baseline on Day -1 and Day 2 for Periods 1 - 3 (49 Days).
Plasma concentration profile as assessed from composite of PK parameters of GSK1265744.
Plasma concentration profile of GSK1265744 will be assessed to characterize PK/PD relationship between exposure of GSK1265744 and changes in QTcF, QTcB and QTci. PK parameters to be assessed for plasma concentration profile are: area under the concentration-time curve from zero to 24 hours (AUC \[0-24\]), AUC (0-t), AUC (0-infinity), and Cmax.
Time frame: Blood samples will be collected at following time points: Day 1 pre-dose (15 minutes prior to first dose 1), and at Day 2 pre-dose (within 15 minutes prior to dosing), 0.5, 1, 2, 3, 4, 6.5, 8, 12, and 24 hours post last dose in each period.
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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Acquired Immunodeficiency Syndrome→
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