A Relative Bioavailability Study of FOR-6219 in Capsule and Tablet Formulations (NCT04686669) | Clinical Trial Compass
CompletedPhase 1
A Relative Bioavailability Study of FOR-6219 in Capsule and Tablet Formulations
United Kingdom12 participantsStarted 2020-12-10
Plain-language summary
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)
Who can participate
Age range
45 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female participants between 45 and 65 years (inclusive) at screening
* Female participants must be either naturally (spontaneously) post-menopausal: Natural (spontaneous) postmenopause is defined as being amenorrheic for at least 12 months without an alternative medical cause with a screening follicle stimulating hormone level \>25.8 IU/L and 17β-oestradiol serum levels less than 183 pmol/L (or the local laboratory levels for post-menopause) OR Must have had a bilateral oophorectomy/bilateral salpingo-oophorectomy. Hysterectomised women can be included only if they have had bilateral oophorectomy.
* Participants not taking hormone replacement therapy (HRT).
* Has a body weight between 50kg and 100kg inclusive and a body mass index (BMI) between 18.5-30.0 kg/m\^2 inclusive.
* Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluation (haematology, biochemistry, coagulation and urinalysis) that is reasonably likely to interfere with the participant's participation in or ability to complete the study as assessed by the investigator.
* Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH Good Clinical Practice (GCP) Guideline E6 (R2) (2016) and applicable regulations, before completing any study-related procedures.
* Ability to swallow t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Ratio of Peak Plasma Concentration (Cmax) after single dose of FOR-6219 tablet (fasted) over soft gelatine capsule (fasted) for FOR-6219.
Timeframe: Up to 48 hours postdose
2
Ratio of Area under the plasma concentration versus time curve (AUC) after single dose of FOR-6219 tablet (fasted) over soft gelatine capsule (fasted) for FOR-6219.
Timeframe: Up to 48 hours postdose
3
Ratio of Peak Plasma Concentration (Cmax) after single dose of FOR-6219 tablet (fed) over tablet (fasted) for FOR-6219.
Timeframe: Up to 48 hours postdose
4
Ratio of Area under the plasma concentration versus time curve (AUC) after single dose of FOR-6219 tablet (fed) over tablet (fasted) for FOR-6219.