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

Forendo Pharma Ltd1 site in 1 country12 target enrollmentDecember 10, 2020

ConditionsRelative Bioavailability

InterventionsFOR-6219 capsule formulation FOR-6219 tablet formulation

DrugsFOR-6219 capsule formulation FOR-6219 tablet formulation

Overview

Phase: Phase 1
Intervention: FOR-6219 capsule formulation
Conditions: Relative Bioavailability
Sponsor: Forendo Pharma Ltd
Enrollment: 12
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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)

Registry

clinicaltrials.gov

Start Date

December 10, 2020

End Date

January 16, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

Forendo Pharma Ltd

Responsible Party

Sponsor

Eligibility Criteria

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 three capsules and tablets at a time or (consecutively) one capsule at a time.
•An understanding, ability, and willingness to fully comply with study procedures and restrictions.

Exclusion Criteria

•Post-menopausal women with less than 12 months amenorrhoea, or women with amenorrhoea due to other medical causes.
•Current or recurrent disease (e.g., cardiovascular, haematological, neurological, endocrine, immunological, renal, hepatic or gastrointestinal or other conditions) that could affect the action, absorption, or disposition of FOR-6219, or could affect clinical laboratory evaluations.
•Current or relevant history of physical or psychiatric illness that are not stable or may require a change in treatment, use of prohibited therapies during the study or make the participant unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.
•Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study may influence the result of the study, or the participant's ability to participate in the study.
•The history or presence of any of the following cardiac conditions: known structural cardiac abnormalities; family history of long QT syndrome; cardiac syncope or recurrent, idiopathic syncope; exercise-related clinically significant cardiac events.
•Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG or clinically important abnormalities that may interfere with the interpretation of QTc interval changes.
•Has vital signs consistently outside of the following normal range. Supine blood pressure (after at least 5 minutes of supine rest): Systolic blood pressure: 90 - 140 mmHg, Diastolic blood pressure: 40 - 90 mmHg.
•Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening.
•Evidence of pregnancy
•Any other abnormal findings on vital signs, ECG, physical examination or laboratory evaluation of blood and urine samples that the Investigator judges as likely to interfere with the study or pose an additional risk in participating.

Arms & Interventions

Subjects receiving treatment sequence ABC

Subjects will receive treatment sequence ABC on Days 1, 3 and 5 respectively; A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state, B= 3x50 milligrams FOR-6219 tablet given in fed state, C= 3x50 milligrams FOR-6219 tablet given in fasted state.