HIV Infections
Conditions
Keywords
Temsavir, Fostemsavir, Bioavailability, Extended Release tablet, GSK3684934, Food effect
Brief summary
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.
Interventions
DRUGFostemsavir 600 mg
Fostemsavir tablets will be administered via oral route.
DRUGFostemsavir 200 mg
Fostemsavir tablets will be administered via oral route.
Sponsors
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study
Intervention model description
This is a two-part study, where Part 1 will be conducted as a randomized three period, three treatment crossover study and Part 2 will have a randomized two period, two treatment crossover design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 to 50 years of age inclusive. * Healthy as determined by the investigator or medically qualified designee. * A participant with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or
Exclusion criteria
, outside the reference range for the population being studied may be included only if the investigator, in consultation with the Medical Monitor, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures. * Body weight \>= 50 kilograms (kg) (110 pounds \[lbs.\]) for men and \>= 45 kg (99 lbs.) for women and body mass index (BMI) within the range 18.5-31.0 kilogram per meter square (kg/m\^2) (inclusive). * Male participants are eligible to participate if they agree to use contraceptive methods. * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: Is a woman of non-childbearing potential (WONCBP). OR Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective. * Capable of giving signed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Area under the plasma concentration-time curve (AUC) from time zero to the last quantifiable time point (AUC[0-t]) of temsavir | Predose (Day 1) until 72 hour post dose |
| Part 1: AUC from time zero extrapolated to infinite time (AUC[0-infinity]) of temsavir | Predose (Day 1) until 72 hour post dose |
| Part 1: Maximum observed plasma concentration (Cmax) | Predose (Day 1) until 72 hour post dose |
Secondary
| Measure | Time frame |
|---|---|
| Part 1 and Part 2: Number of participants with clinically significant change from Baseline in vital signs and clinical laboratory parameters | 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) | Baseline (Day -1) until end of follow up at 4 weeks |
| Part 1: Time to Cmax (Tmax) of temsavir | Predose (Day 1) until 72 hour post dose |
| Part 2: AUC [0-infinity] of temsavir | Predose (Day 1) until 72 hour post dose |
| Part 2: Cmax of temsavir | Predose (Day 1) until 72 hour post dose |
| Part 2: AUC [0-t] of temsavir | Predose (Day 1) until 72 hour post dose |
| Part 1: Elimination half-life (T1/2) of temsavir | Predose (Day 1) until 72 hour post dose |
| Part 1: Concentration at 12 hours post-dose of temsavir | 12 hours post-dose |
Countries
United States
Outcome results
None listed