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NCT04686669

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

Completed Phase 1 Last updated 29 January 2021
What this trial tests

Phase 1 trial testing FOR-6219 capsule formulation in Relative Bioavailability in 12 participants. Completed in 16 January 2021.

Timeline
10 December 2020
Primary endpoint
16 January 2021
16 January 2021

Quick facts

Lead sponsorForendo Pharma Ltd
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposeother
Enrollment12
Start date10 December 2020
Primary completion16 January 2021
Estimated completion16 January 2021
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

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):

  1. 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

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Other Forendo Pharma Ltd trials

Trials by the same sponsor.

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