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NCT04686669
A Relative Bioavailability Study of FOR-6219 in Capsule and Tablet Formulations
Phase 1 trial testing FOR-6219 capsule formulation in Relative Bioavailability in 12 participants. Completed in 16 January 2021.
16 January 2021
Quick facts
| Lead sponsor | Forendo Pharma Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | other |
| Enrollment | 12 |
| Start date | 10 December 2020 |
| Primary completion | 16 January 2021 |
| Estimated completion | 16 January 2021 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- FOR-6219 capsule formulation
- FOR-6219 tablet formulation
Conditions studied
- Relative Bioavailability — all drugs for Relative Bioavailability →
Sponsor
Forendo Pharma Ltd — full company profile →
Who can join
Adults 45 to 65, female only, with Relative Bioavailability. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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)
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Targeting the formation of estrogens for treatment of hormone dependent diseases-current status.
Rižner TL, Romano A. · · 2023 · cited 16× · PMID 37188267 · DOI 10.3389/fphar.2023.1155558
Verify or expand the search:
- PubMed search for NCT04686669
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other Forendo Pharma Ltd trials
Trials by the same sponsor.
- NCT03709420 — A Study to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics and Pharmacodynamics of FOR-6219 · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04686669 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Forendo Pharma Ltd
- Last refreshed: 29 January 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04686669.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing