This will be a single-center, two-cohort, three-period study in healthy adult subjects. Approximately 16 healthy subjects will be enrolled in Cohort 1 to provide data from 14 evaluable subjects. Approximately 12 healthy subjects will be enrolled in Cohort 2 to provide data from 10 evaluable subjects. Subjects will have a screening visit within 30 days prior to the first dose of study drug, three treatment periods, and a follow-up visit 7-14 days after the last dose of study drug. There will be a washout period between Period 1 and Period 2 but no washout between Period 2 and Period 3. Day 1 of Period 3 will start the day after the last day in Period 2. The study will be conducted on an out-patient basis except for days where serial pharmacokinetic sampling and safety assessments are scheduled.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Masking
NONE
Enrollment
28
50mg q 24h
25mg q24h
30mg q24h
GSK Investigational Site
Buffalo, New York, United States
Composite of Pharmacokinetic Parameters following Dolutegravir administration with and without rilpivirine
Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments (AUC(0-tau)), Maximum observed concentration (Cmax), Time of occurrence of Cmax (tmax), Pre-dose (trough) concentration at the end of the dosing interval (Ctau)
Time frame: Cohort 1: Period 1 and 3 on Day 5: pre-dose, 1, 2, 3, 4, 8, 12 and 24 hours post dose.
Composite of Pharmacokinetic Parameters following GSK1265744 administration with and without rilpivirine
steady state, AUC(0-t), Cmax, tmax, and Ctau
Time frame: Cohort 2: Period 2 and 3, Day 12: pre-dose, 1, 2, 3, 4, 5, 6, 9, 12, 16, and 24hrs post dose.
Composite of Pharmacokinetic Parameters following rilpivirine administration with and without Dolutegravir
steady state, AUC(0-tau), Cmax, tmax, and Ctau
Time frame: Cohort 1: Period 2, Day 11: pre-dose, 1, 2, 3, 4, 5, 6, 9, 12, 16, and 24hrs post dose. Period 3: Day 5 pre-dose 1, 2, 3, 4, 5, 6, 9, 12, 16, and 24hrs post dose
Composite of Pharmacokinetic Parameters following rilpivirine administration with and without GSK1265744
AUC(0-tau), Cmax, tmax, and Ctau
Time frame: Cohort 2: Periods 1 and 3: Day 12: pre-dose, 1, 2, 3, 4, 8, 12 and 24hrs post dose
Safety and tolerability parameters, including the collection of all adverse events
Collected from first dose to final visit.
Time frame: 42 days or final visit has occurred
Safety and tolerability parameters, including the collection of any concurrent medication from first dose to final visit
Collected from first dose to final visit.
Time frame: 42 days or final visit has occurred
Safety and tolerability parameters, including change from baseline in clinical laboratory tests (hematology, chemistry, urinalysis) assessments
Time frame: 42 days or final assessment has occurred
Safety and tolerability parameters, including change from baseline in ECG assessments
Time frame: 42 days or final assessment has occurred
Safety and tolerability parameters, including change from baseline in vital signs assessments
Time frame: 42 days or final assessment has occurred
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