NCT04757974

Low-dose Fostemsavir Extended Release Relative Bioavailability Study

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: ViiV Healthcare · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV Infections

Interventions

Type	Name	Description
DRUG	Fostemsavir 600 mg	Fostemsavir tablets will be administered via oral route.
DRUG	Fostemsavir 200 mg	Fostemsavir tablets will be administered via oral route.

Timeline

• Start date: 2021-03-05
• Primary completion: 2021-07-31
• Completion: 2021-07-31
• First posted: 2021-02-17
• Last updated: 2021-09-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study