NCT03709420

A Study to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics and Pharmacodynamics of FOR-6219

A Phase I/Ib, Randomised, Double-blind, Placebo-controlled Study in Healthy Postmenopausal and Pre-menopausal Women to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics of Single and Multiple Ascending Oral Doses of FOR-6219 and the Pharmacodynamics of Multiple Oral Doses of FOR-6219

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Forendo Pharma Ltd · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a randomised, double-blind, placebo-controlled, Phase I/Ib study which will assess the safety, tolerability, food effect, pharmacokinetics and pharmacodynamics of FOR-6219, a hydroxysteroid (17B) dehydrogenase (HSD17B1) inhibitor. The study will be performed in three parts: (I) Single ascending doses (SAD) in healthy post-menopausal women; (II) multiple ascending doses (MAD) in post-menopausal women; (III) multiple ascending doses in healthy pre-menopausal women.

Conditions

• Endometriosis

Interventions

Type	Name	Description
DRUG	Placebo	Placebo capsule to match active drug
DRUG	FOR-6219	FOR-6219 capsule

Timeline

• Start date: 2018-08-13
• Primary completion: 2020-11-11
• Completion: 2020-11-11
• First posted: 2018-10-17
• Last updated: 2020-11-18

Locations

1 site across 1 country: United Kingdom