Relative BioavailabilityPhase 1NCT04686669

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

A Phase 1 study testing FOR-6219 capsule formulation and FOR-6219 tablet formulation in people with Relative Bioavailability, run by Forendo Pharma Ltd at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 45 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Relative Bioavailability
What is being tested?: FOR-6219 capsule formulation and FOR-6219 tablet formulation
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteUnited Kingdom
Study dates: 10 Dec 2020to 16 Jan 2021
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.
Positive test results for alcohol or drugs of abuse.
History or clinical evidence of substance and/or alcohol abuse within the two years before screening.
Use of tobacco in any form (e.g., smoking or chewing) or other nicotine-containing products in any form (e.g., gum, patch, electronic cigarettes) within three months prior to the planned first day of dosing.
Has used any medication that is either an inhibitor or inducer of CYP3A4 within 28 days or 10 half-lives (whichever is longer) prior to the planned first day of dosing. Additionally, participants must not have consumed other substances known to be potent inhibitors or inducers of cytochrome P450 (CYP P450s) in the two weeks before the planned first study drug administration.
Has used any other prescription or over-the-counter medication (including herbal or homeopathic preparations; excluding vitamin/mineral supplements and occasional paracetamol) within 14 days or 10 half-lives (whichever is longer) prior to the planned first day of dosing that the Investigator judges is likely to interfere with the study or pose an additional risk in participating.
Consumption of herbal remedies or dietary supplements containing St. John's Wort in the 3 weeks before the planned Day 1 of the dosing period.
Has received an investigational product or been treated with an investigational device within 90 days prior to first drug administration and will not start any other investigational product or device study within 90 days after last study drug administration.
Known or suspected intolerance or hypersensitivity to the investigational product, any closely related compound, or any of the stated ingredients.
History of significant allergic reaction (anaphylaxis, angioedema) to any product (food, pharmaceutical, etc).
Has donated or lost 400 mL blood or more within the last 16 weeks preceding the first day of dosing.
Has a mental incapacity or language barriers precluding adequate understanding, cooperation, and compliance with the study requirements.
An inability to follow a standardised diet and meal schedule or inability to fast, as required during the study.
Prior screen failure (where the cause of the screen failure is not deemed to be temporary), randomisation, participation, or enrolment in this study. Participants who initially failed due to temporary non-medically significant issues are eligible for rescreening once the cause has resolved.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Richmond Pharmacology Ltd.
London

Other trials in United Kingdom

About this study

Official title: 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

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)

Conditions: Relative Bioavailability
Being tested: FOR-6219 capsule formulation, FOR-6219 tablet formulation
Keywords: HSD17B1 inhibitor, Endometriosis, Food-effect, Bioavailability
Medical subject headings: Endometriosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FOR-6219 capsule formulationDrug
FOR-6219 capsule formulation will be available as a soft gelatine capsule with a single dose of 50 milligrams, administered orally.
FOR-6219 tablet formulationDrug
FOR-6219 tablet formulation will be available as a tablet with a single dose of 50 milligrams, administered orally.

Study groups in NCT04686669
Study group	Role	What they receive
Subjects receiving treatment sequence ABC	Experimental	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. Receives: Drug: FOR-6219 capsule formulation; Drug: FOR-6219 tablet formulation
Subjects receiving treatment sequence BCA	Experimental	Subjects will receive treatment sequence BCA on Days 1, 3 and 5 respectively; B= 3x50 milligrams FOR-6219 tablet given in fed state, C= 3x50 milligrams FOR-6219 tablet given in fasted state, A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state. Receives: Drug: FOR-6219 capsule formulation; Drug: FOR-6219 tablet formulation
Subjects receiving treatment sequence CAB	Experimental	Subjects will receive treatment sequence CAB on Days 1, 3 and 5 respectively; C= 3x50 milligrams FOR-6219 tablet given in fasted state, A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state, B= 3x50 milligrams FOR-6219 tablet given in fed state. Receives: Drug: FOR-6219 capsule formulation; Drug: FOR-6219 tablet formulation
Subjects receiving treatment sequence ACB	Experimental	Subjects will receive treatment sequence ACB on Days 1, 3 and 5 respectively; A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state, C= 3x50 milligrams FOR-6219 tablet given in fasted state, B= 3x50 milligrams FOR-6219 tablet given in fed state. Receives: Drug: FOR-6219 capsule formulation; Drug: FOR-6219 tablet formulation
Subjects receiving treatment sequence BAC	Experimental	Subjects will receive treatment sequence BAC on Days 1, 3 and 5 respectively; B= 3x50 milligrams FOR-6219 tablet given in fed state, A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state, C= 3x50 milligrams FOR-6219 tablet given in fasted state. Receives: Drug: FOR-6219 capsule formulation; Drug: FOR-6219 tablet formulation
Subjects receiving treatment sequence CBA	Experimental	Subjects will receive treatment sequence CBA on Days 1, 3 and 5 respectively; C= 3x50 milligrams FOR-6219 tablet given in fasted state, B= 3x50 milligrams FOR-6219 tablet given in fed state, A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state. Receives: Drug: FOR-6219 capsule formulation; Drug: FOR-6219 tablet formulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Ratio of Peak Plasma Concentration (Cmax) after single dose of FOR-6219 tablet (fasted) over soft gelatine capsule (fasted) for FOR-6219.
Measured: Up to 48 hours postdose
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.
Measured: Up to 48 hours postdose
Ratio of Peak Plasma Concentration (Cmax) after single dose of FOR-6219 tablet (fed) over tablet (fasted) for FOR-6219.
Measured: Up to 48 hours postdose
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.
Measured: Up to 48 hours postdose

Secondary outcomes (16)

Peak plasma concentration (Cmax)
Measured: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Time to peak plasma concentration (Tmax)
Measured: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Terminal half-life (t½)
Measured: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Area under the plasma concentration versus time curve (AUC)
Measured: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Apparent total plasma clearance (CL/f)
Measured: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Apparent volume of distribution during terminal phase (Vz/f)
Measured: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Incidence of Treatment Emergent Adverse Events (TEAE)
Measured: Adverse Events will be monitored from screening to 96 hours after the last FOR-6219 dose
Proportion of participants with morphological or rhythm abnormalities on Electrocardiograms (ECGs)
12-lead ECGs will be used to measure ECG
Measured: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in Electrocardiogram (ECG) PR time interval
12-lead ECGs will be used to measure ECG
Measured: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in Electrocardiogram (ECG) QRS time interval
12-lead ECGs will be used to measure ECG
Measured: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in Electrocardiogram (ECG) QT time interval
12-lead ECGs will be used to measure ECG
Measured: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in Electrocardiogram (ECG) QTc interval
12-lead ECGs will be used to measure ECG
Measured: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in laboratory safety tests
Laboratory safety tests include haematology, chemistry, coagulation and urinalysis
Measured: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in systolic blood pressure
Blood pressure will be measured using automated monitors in supine position after 5 minute rest.
Measured: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in diastolic blood pressure
Blood pressure will be measured using automated monitors in supine position after 5 minute rest.
Measured: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in pulse rate
Pulse rate will be measured using automated monitors in supine position after 5 minute rest.
Measured: From Day -1 until 96 hours after the last FOR-6219 dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Dec 202016 Jan 2021

First posted29 Dec 2020
Study start10 Dec 2020
Primary completion16 Jan 2021
Study completion16 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Relative BioavailabilityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 12 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04686669
Sponsor's protocol ID: 40-533-002
Status last verified: Jan 2021
First submitted: 11 Dec 2020
Last updated: 29 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT04686669
Acronym / sponsor ID: 40-533-002
Conditions: Relative Bioavailability
Keywords: HSD17B1 inhibitor, Endometriosis, Food-effect, Bioavailability
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (actual)
Lead sponsor: Forendo Pharma LtdIndustry (pharma, biotech, devices)
Collaborators: Richmond Pharmacology Limited
Study start: 10 Dec 2020 (actual)
Primary completion: 16 Jan 2021 (actual)
Study completion: 16 Jan 2021 (actual)
First posted: 29 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Subjects receiving treatment sequence ABC	Experimental	Drug: FOR-6219 capsule formulation, Drug: FOR-6219 tablet formulationSubjects 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.
Subjects receiving treatment sequence BCA	Experimental	Drug: FOR-6219 capsule formulation, Drug: FOR-6219 tablet formulationSubjects will receive treatment sequence BCA on Days 1, 3 and 5 respectively; B= 3x50 milligrams FOR-6219 tablet given in fed state, C= 3x50 milligrams FOR-6219 tablet given in fasted state, A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state.
Subjects receiving treatment sequence CAB	Experimental	Drug: FOR-6219 capsule formulation, Drug: FOR-6219 tablet formulationSubjects will receive treatment sequence CAB on Days 1, 3 and 5 respectively; C= 3x50 milligrams FOR-6219 tablet given in fasted state, A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state, B= 3x50 milligrams FOR-6219 tablet given in fed state.
Subjects receiving treatment sequence ACB	Experimental	Drug: FOR-6219 capsule formulation, Drug: FOR-6219 tablet formulationSubjects will receive treatment sequence ACB on Days 1, 3 and 5 respectively; A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state, C= 3x50 milligrams FOR-6219 tablet given in fasted state, B= 3x50 milligrams FOR-6219 tablet given in fed state.
Subjects receiving treatment sequence BAC	Experimental	Drug: FOR-6219 capsule formulation, Drug: FOR-6219 tablet formulationSubjects will receive treatment sequence BAC on Days 1, 3 and 5 respectively; B= 3x50 milligrams FOR-6219 tablet given in fed state, A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state, C= 3x50 milligrams FOR-6219 tablet given in fasted state.
Subjects receiving treatment sequence CBA	Experimental	Drug: FOR-6219 capsule formulation, Drug: FOR-6219 tablet formulationSubjects will receive treatment sequence CBA on Days 1, 3 and 5 respectively; C= 3x50 milligrams FOR-6219 tablet given in fasted state, B= 3x50 milligrams FOR-6219 tablet given in fed state, A= 3x50 milligrams FOR-6219 soft gelatine capsule given in fasted state.

Who may qualify

Ages: 45 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (23 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FOR-6219 capsule formulationFOR-6219 capsule formulation will be available as a soft gelatine capsule with a single dose of 50 milligrams, administered orally.	Drug	Subjects receiving treatment sequence ABC, Subjects receiving treatment sequence ACB, Subjects receiving treatment sequence BAC, Subjects receiving treatment sequence BCA, Subjects receiving treatment sequence CAB, Subjects receiving treatment sequence CBA
FOR-6219 tablet formulationFOR-6219 tablet formulation will be available as a tablet with a single dose of 50 milligrams, administered orally.	Drug	Subjects receiving treatment sequence ABC, Subjects receiving treatment sequence ACB, Subjects receiving treatment sequence BAC, Subjects receiving treatment sequence BCA, Subjects receiving treatment sequence CAB, Subjects receiving treatment sequence CBA

Primary outcome

Ratio of Peak Plasma Concentration (Cmax) after single dose of FOR-6219 tablet (fasted) over soft gelatine capsule (fasted) for FOR-6219.
Time frame: Up to 48 hours postdose
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.
Time frame: Up to 48 hours postdose
Ratio of Peak Plasma Concentration (Cmax) after single dose of FOR-6219 tablet (fed) over tablet (fasted) for FOR-6219.
Time frame: Up to 48 hours postdose
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.
Time frame: Up to 48 hours postdose

16 secondary outcomes

Peak plasma concentration (Cmax)
Time frame: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Time to peak plasma concentration (Tmax)
Time frame: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Terminal half-life (t½)
Time frame: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Area under the plasma concentration versus time curve (AUC)
Time frame: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Apparent total plasma clearance (CL/f)
Time frame: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Apparent volume of distribution during terminal phase (Vz/f)
Time frame: Blood sampling up to the end of each treatment period: Up to 48 hours after the FOR-6219 dose in Period 1 and Period 2 and up to 96 hours after the FOR-6219 dose in Period 3
Incidence of Treatment Emergent Adverse Events (TEAE)
Time frame: Adverse Events will be monitored from screening to 96 hours after the last FOR-6219 dose
Proportion of participants with morphological or rhythm abnormalities on Electrocardiograms (ECGs)
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in Electrocardiogram (ECG) PR time interval
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in Electrocardiogram (ECG) QRS time interval
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in Electrocardiogram (ECG) QT time interval
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in Electrocardiogram (ECG) QTc interval
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in laboratory safety tests
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in systolic blood pressure
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in diastolic blood pressure
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose
Proportion of participants with clinically significant changes in pulse rate
Time frame: From Day -1 until 96 hours after the last FOR-6219 dose

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2021.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ulrike Lorch, M.D. principal investigator

Richmond Pharmacology Limited

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FOR-6219 capsule formulation and FOR-6219 tablet formulation in people with Relative Bioavailability, run by Forendo Pharma Ltd at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ratio of Peak Plasma Concentration (Cmax) after single dose of FOR-6219 tablet (fasted) over soft gelatine capsule (fasted) for FOR-6219. (time frame: Up to 48 hours postdose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04686669.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2021; AzTrials last refreshed its copy on 6 Nov 2026.