This is a two-part study. Part 1 will evaluate relative bioavailability of temsavir (TMR) following single dose administration of the reference fostemsavir (FTR) compared to two low-dose ER tablet formulations of FTR. In Part 2, the effect of food on the bioavailability of TMR will be assessed on the selected low-dose ER tablet formulation from Part 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
Fostemsavir tablets will be administered via oral route.
Fostemsavir tablets will be administered via oral route.
GSK Investigational Site
Austin, Texas, United States
Part 1: Area under the plasma concentration-time curve (AUC) from time zero to the last quantifiable time point (AUC[0-t]) of temsavir
Time frame: Predose (Day 1) until 72 hour post dose
Part 1: AUC from time zero extrapolated to infinite time (AUC[0-infinity]) of temsavir
Time frame: Predose (Day 1) until 72 hour post dose
Part 1: Maximum observed plasma concentration (Cmax)
Time frame: Predose (Day 1) until 72 hour post dose
Part 1: Time to Cmax (Tmax) of temsavir
Time frame: Predose (Day 1) until 72 hour post dose
Part 1: Elimination half-life (T1/2) of temsavir
Time frame: Predose (Day 1) until 72 hour post dose
Part 1: Concentration at 12 hours post-dose of temsavir
Time frame: 12 hours post-dose
Part 1 and Part 2: Number of participants with clinically significant change from Baseline in vital signs and clinical laboratory parameters
Time frame: Baseline (Day -1) until end of follow up at 4 weeks
Part 1 and Part 2: Number of participants reporting adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline (Day -1) until end of follow up at 4 weeks
Part 2: AUC [0-t] of temsavir
Time frame: Predose (Day 1) until 72 hour post dose
Part 2: AUC [0-infinity] of temsavir
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Predose (Day 1) until 72 hour post dose
Part 2: Cmax of temsavir
Time frame: Predose (Day 1) until 72 hour post dose