A single dose escalation study to determine the safety, tolerability, and pharmacokinetic profile of intramuscular and subcutaneous injections of GSK1265744 long acting parenteral (LAP) in healthy subjects. This study consists of a screening visit, a single injection, and follow-up evaluations for a minimum of 12 weeks following the injection.
ViiV Healthcare is the new sponsor of this study, and GlaxoSmithKline is in the process of updating systems to reflect the change in sponsorship
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
SINGLE
Enrollment
72
200 milligram per milliliter sterile solution for injection
placebo
GSK1265744 safety and tolerability parameters including: the collection of adverse events
Time frame: 12 weeks
Change from baseline values in clinical laboratory assessments
Time frame: 12 weeks
Change from baseline for Electrocardiogram (ECG) assessments
Time frame: 12 weeks
Change from baseline valuse in vital sign assessments (systolic and diastolic blood pressure and pulse rate)
Time frame: 12 weeks
Composite of pharmacokinetic parameters: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks
GSK1265744 pharmacokinetic parameters: area under the plasma concentration time curve from time zero to the last quantifiable time points (AUC(0-tau)), area under the plasma concentration time curve from time zero to infinity (AUC(0-infinity)), maximum observed concentration (Cmax), time to maximum observed concentration (tmax), apparent terminal phase half-life for LAP administration (t½), lambda z as a measure of absorption rate constant
Time frame: 12 weeks
GSK1265744 concentration at 1 month post-dose (C720 hours)
Time frame: 4 weeks
Composite of pharmacokinetic parameters: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks.
GSK1265744 pharmacokinetic parameters: absorption lag time (tlag), apparent clearance (CL/F,LAP) following single dose administration, Percentage of AUC(0-infinity) obtained by extrapolation (AUC%ex)
Time frame: 12 weeks
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Composite of pharmacokinetic parameters for dose proportionality: pre-dose and at 4, 8, 12 hours, Day 2, Days 3, 4, 5, 6, 7, Weeks 3, 4, 5, 6, 8, 12 and every 4 weeks until GSK1265744 is less than 0.10 or until 24 weeks
GSK1265744 following single dose administration at different doses for the assessment of dose proportionality: AUC(0-infinity), AUC(0-tau), Cmax
Time frame: 12 weeks
GSK1265744 C720 hours following single dose administration at different doses for the assessment of dose proportionality
Time frame: 12 weeks
GSK1265744 concentrations in cervicovaginal fluid (CVF), cervical tissue (CT), vaginal tissue (VT), rectal tissue (RT), and blood plasma and ratio of CVF, CT, VT, and RT concentration to blood plasma
Cohort 8 at week 2 and week 8; Cohort 9 at week 4 and week 12
Time frame: Cohort 8 at week 2 and week 8; Cohort 9 at week 4 and week 12