Study comparing BA of FOR-6219 formulations in postmenopausal women
Research type
Research Study
Full title
A phase 1, randomised, open-label, 3-way, 3-period, crossover relative bioavailability study to assess the single-dose pharmacokinetics of FOR-6219 in capsule and tablet formulations in postmenopausal women
IRAS ID
289754
Contact name
Ulrike Lorch
Contact email
Sponsor organisation
Forendo Pharma
Eudract number
2020-004525-23
Duration of Study in the UK
0 years, 0 months, 10 days
Research summary
Summary of Research
Richmond Pharmacology are conducting clinical trials aimed at improving the diagnosis and treatment of endometriosis. Endometriosis is a debilitating disease that can cause women a significant amount of pain over many years. Some studies suggest that around 10% of women of reproductive age have endometriosis and despite this, it is poorly understood and remains difficult to treat in many individuals(1).FOR-6219 is an investigational drug under development for the treatment of endometriosis. It has been successfully dosed in volunteers in a Phase 1 study and has been shown to have a favourable safety and tolerability profile. The IMP has so far been administered as a soft gelatine capsule formulation.
This is a bioequivalence study taking place in 12 post-menopausal, female volunteers. It seeks to assess how the drug is absorbed and behaves in the body when given as a tablet formation. Tablets have the advantage of maintaining drug stability for a longer period of time, and as such are a favourable treatment method.
The volunteers will have a residential stay of 9 days and receive the drug on days 1, 3 and 5. Each time the drug will be given under different conditions: Treatment A (soft gelatine capsule when fasted); Treatment B (tablet formation fed); Treatment C (tablet formation fasted). By collecting and comparing this data, this study will be able to assess the different formulations under different conditions. This data has the potential to be very beneficial for endometriosis patients.
References
1. https://www.ncbi.nlm.nih.gov/pubmed/25408753Summary of Results
Forendo Pharma is developing a novel HSD17B1 enzyme inhibitor, FOR-6219, for the treatment of endometriosis in women. The pharmacological action of FOR-6219 is based on its binding to HSD17B1 enzyme and ability to inhibit estradiol production.The single dose administrations of FOR-6219 in capsule and tablet formulations were well tolerated in postmenopausal women. No deaths or SAEs occurred during the study and no subjects were withdrawn due to a treatment-emergent adverse event (TEAE). A TEAE is defined as an event that first appears during treatment, which was absent before or which worsens relative to the pre-treatment state.
A total of eight TEAEs were reported across all subjects, which were of mild severity and seven of these had fully resolved by the end of the study period, with the eighth been classified as resolving at the end of the study period. There were no clinically significant changes in electrocardiogram (ECG) parameters, vital signs, physical examination findings or clinical laboratory tests across the study.
The bioavailability (the degree to which the drug is absorbed into a human body) of the tablet formulation was similar to that of the soft gelatine capsule. There was no meaningful difference on the bioavailability of FOR-6219 when given as the tablet formulation between fed and fasted state.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0370
Date of REC Opinion
12 Nov 2020
REC opinion
Favourable Opinion