drugset / Trial / NCT04757974

Low-dose Fostemsavir Extended Release Relative Bioavailability Study

NCT04757974

Phase 1 Completed 32 enrolled ViiV Healthcare
RandomizedCrossoverOpen-labelTreatment

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.

Timeline

Start
2021-03-05
Primary completion
2021-07-31
Completion
2021-07-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Fostemsavir Other / unclassified 200 mg Oral
Subject Fostemsavir Other / unclassified 600 mg Oral