NCT04686669

A Relative Bioavailability Study of FOR-6219 in Capsule and Tablet Formulations

A Phase 1, Randomised, Open-Label, Three-way, Three-period, Crossover Relative Bioavailability Study to Assess the Single-Dose Pharmacokinetics of FOR-6219 in Capsule and Tablet Formulations in Postmenopausal Women

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Forendo Pharma Ltd · Industry
• Sex: Female
• Age: 45 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, randomised, open-label, three-way, three-period, crossover relative bioavailability study to assess the single-dose pharmacokinetics of FOR-6219 in capsule and tablet formulations in postmenopausal women. The effect of high-fat food on the pharmacokinetics of the tablet formulation will also be evaluated. A total of twelve, post-menopausal women, will be randomised to receive a single oral dose of FOR-6219 in three treatment periods: capsule formulation (fasted); tablet formulation (fed); tablet formulation (fasted)

Conditions

• Relative Bioavailability

Interventions

Type	Name	Description
DRUG	FOR-6219 capsule formulation	FOR-6219 capsule formulation will be available as a soft gelatine capsule with a single dose of 50 milligrams, administered orally.
DRUG	FOR-6219 tablet formulation	FOR-6219 tablet formulation will be available as a tablet with a single dose of 50 milligrams, administered orally.

Timeline

• Start date: 2020-12-10
• Primary completion: 2021-01-16
• Completion: 2021-01-16
• First posted: 2020-12-29
• Last updated: 2021-01-29

Locations

1 site across 1 country: United Kingdom