GSK Investigational Site
Austin, Texas, 78744, United States
NCT Number: NCT04757974
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.
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Notify Me18 year–50 year
All sexes
Interventional
Phase 1
Austin, Texas, 78744, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Fostemsavir tablets will be administered via oral route.
Fostemsavir tablets will be administered via oral route.
Time frame: Predose (Day 1) until 72 hour post dose
Time frame: Predose (Day 1) until 72 hour post dose
Time frame: Predose (Day 1) until 72 hour post dose
Time frame: Predose (Day 1) until 72 hour post dose
Time frame: Predose (Day 1) until 72 hour post dose
Time frame: 12 hours post-dose
Time frame: Baseline (Day -1) until end of follow up at 4 weeks
Time frame: Baseline (Day -1) until end of follow up at 4 weeks
Time frame: Predose (Day 1) until 72 hour post dose
Time frame: Predose (Day 1) until 72 hour post dose
Time frame: Predose (Day 1) until 72 hour post dose
ViiV Healthcare
Industry
A Two-Part Randomized Study to Evaluate the Relative Bioavailability of Temsavir Following Single Dose Administration of Fostemsavir 600 mg Tablets Compared to Two Fostemsavir 200 mg Tablet Formulations and to Evaluate the Effect of Food on Bioavailability of Selected Fostemsavir 200 mg Tablet Formulation in Healthy Adult Participants
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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