Ignite Creation Date:
2024-05-06 @ 12:14 PM
Last Modification Date:
2024-10-26 @ 12:56 PM
Study NCT ID:
NCT03709420
Status:
COMPLETED
Last Update Posted:
2020-11-18
First Post:
2018-10-08
Brief Title:
A Study to Investigate the Safety Tolerability Food Effect Pharmacokinetics and Pharmacodynamics of FOR-6219
Sponsor:
Forendo Pharma Ltd
Organization:
Forendo Pharma Ltd
Study Overview
Official Title:
A Phase IIb 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
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomised double-blind placebo-controlled Phase IIb 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None