EndometriosisPhase 1NCT03709420

A Study to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics and Pharmacodynamics of FOR-6219

A Phase 1 study testing FOR-6219 in people with Endometriosis, 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 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for: Endometriosis
What is being tested?: FOR-6219
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 87 participants
Where: 1 siteUnited Kingdom
Study dates: 13 Aug 2018to 11 Nov 2020
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 18 to 65 years
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy Caucasian female volunteers between 45 and 65 years (inclusive) at screening.
Female volunteers 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.
Volunteers not taking hormone replacement therapy (HRT).
Has a body weight between 50kg and 100kg inclusive and a body mass index (BMI) between 18.0-32.0 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 electrocardiogram (ECG), and clinical laboratory evaluation (haematology, biochemistry, coagulation and urinalysis) that is reasonably likely to interfere with the volunteer'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 International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guideline E6 (R2) (2016) and applicable regulations, before completing any study-related procedures.

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Ability to swallow multiple capsules at a time or (consecutively) one capsule at a time.
An understanding, ability, and willingness to fully comply with study procedures and restrictions.
Healthy female volunteers between age 18-39 years (inclusive) at screening and not planning pregnancy during the month following the study completion.
The subject is premenopausal with a regular ovulatory menstrual cycle with an interval of 26-31 days based on medical history during the past 3 months and as confirmed by the control menstrual cycle prior to dosing.
Volunteers not taking oral contraceptives.
Has a body weight between 45kg and 90kg inclusive and a body mass index (BMI between 18.0-30.0 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 volunteer's participation in or ability to complete the study as assessed by the investigator.
Satisfactory medical assessment with no clinically significant or relevant abnormalities as determined by gynaecological examination and transvaginal ultrasound (TVUS), that would interfere with the assessment of the endometrial thickness or endometrial biopsy.
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 multiple capsules at a time or (consecutively) one capsule at a time.
An understanding, ability, and willingness to fully comply with study procedures and restrictions.
The subjects must agree to use the study-specific contraceptive methods from screening up to 30 days after the follow-up visit.

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 assessments or 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 subject 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 subject at risk because of participation in the study may influence the result of the study, or the subject'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 corrected QT (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 - 145 mmHg.
Diastolic blood pressure: 40 - 95 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, subjects 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. Subjects who initially failed due to temporary non-medically significant issues are eligible for rescreening once the cause has resolved.
PART III (premenopausal women):
Post-menopausal women, defined as with more than 12 months amenorrhoea.
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 assessments or clinical laboratory evaluations.
Current or recurrent gynaecological disease that could affect the clinical assessments.
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 subject 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 subject at risk because of participation in the study may influence the result of the study, or the subject'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.
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, subjects 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, measures for pain relief during biopsy (such as use of local anaesthetic and/or NSAIDs) 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.
Use of oral contraceptives, contraceptive intrauterine device, or any other hormonal medication that may have an impact on the hormonal levels, assessment of endometrium or follicle assessment during the menstrual cycle. The wash-out period for any hormonal treatment is at least 3 menstrual cycles before dosing.
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. Subjects 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 I/Ib, Randomised, Double-blind, Placebo-controlled Study in Healthy Postmenopausal and Pre-menopausal Women to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics of Single and Multiple Ascending Oral Doses of FOR-6219 and the Pharmacodynamics of Multiple Oral Doses of FOR-6219

This is a randomised, double-blind, placebo-controlled, Phase I/Ib study which will assess the safety, tolerability, food effect, pharmacokinetics and pharmacodynamics of FOR-6219, a hydroxysteroid (17B) dehydrogenase (HSD17B1) inhibitor. The study will be performed in three parts: (I) Single ascending doses (SAD) in healthy post-menopausal women; (II) multiple ascending doses (MAD) in post-menopausal women; (III) multiple ascending doses in healthy pre-menopausal women.

Conditions: Endometriosis
Being tested: Placebo, FOR-6219
Keywords: Hydroxysteroid (17B) dehydrogenase, HSD17B1
Medical subject headings: Endometriosis

What participants receive

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

PlaceboDrug
Placebo capsule to match active drug
FOR-6219Drug
FOR-6219 capsule

Study groups in NCT03709420
Study group	Role	What they receive
Placebo	Placebo comparator	Matching placebo capsule Receives: Drug: Placebo
FOR-6219	Experimental	Part I (SAD): Single oral doses of 2 mg, 10 mg, 25 mg, 50 mg, 100 mg and 175 mg. Part II (MAD): Multiple oral doses of 50 mg QD, 75 mg BID and 150 mg BID. Part III: Multiple oral doses of 10 mg, 25 mg, 75 mg and 150 mg BID Receives: Drug: FOR-6219

What is being measured

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

Safety and tolerability as measured by the incidence of treatment-emergent adverse events (TEAEs).
All adverse events will be assessed by the investigator and graded for severity according to the criteria from National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v4.03.
Measured: Throughout the study until the follow-up visit, i.e. 7 days after the last dose in Parts I and II and until day 35 in Part III.
Proportion of subjects with clinically significant changes in laboratory safety tests.
Laboratory safety tests include haematology, chemistry, coagulation and urinalysis.
Measured: Throughout the study until the follow-up visit, i.e. 7 days after the last dose in Parts I and II and until day 35 in Part III.
Proportion of subjects with changes in vital signs (blood pressure, diastolic blood pressure and pulse)
Vital signs will be measures using automated monitors in supine position after 5 minute rest.
Measured: Throughout the study until the follow-up visit, i.e. 7 days after the last dose in Parts I and II and until day 35 in Part III.
Proportion of subjects with ECG changes.
12-lead ECGs and ECG telemetry (only Parts I and II) will be used to measure ECG parameters.
Measured: Throughout the study until the follow-up visit, i.e. 7 days after the last dose in Parts I and II and until day 35 in Part III.
Presence of any pathology in transvaginal ultrasound (Part III).
Transvaginal ultrasound will be performed at multiple timepoints.
Measured: Throughout the study until the day of the last dose (day 14).

Secondary outcomes (9)

Maximum observed plasma concentration (Cmax).
Measured: Pharmacokinetic measures will be taken predose and multiple timepoints postdose after the single dose (SAD) and up to 72 hours after the last dose (Parts II and III).
Area under the plasma concentration-time curve (AUC).
Measured: Pharmacokinetic measures will be taken predose and multiple timepoints postdose after the single dose (SAD) and up to 72 hours after the last dose (Parts II and III).
Time to maximum plasma concentration (Cmax).
Measured: Pharmacokinetic measures will be taken predose and multiple timepoints postdose after the single dose (SAD) and up to 72 hours after the last dose (Parts II and III).
Terminal half-life (t½).
Measured: Pharmacokinetic measures will be taken predose and multiple timepoints postdose after the single dose (SAD) and up to 72 hours after the last dose (Parts II and III).
Effect of food on the pharmacokinetic profile of FOR-6219 and metabolite FOR-6287 based on maximum observed plasma concentration (Cmax) (Part II).
Measured: Predose and multiple timepoints post-dose in fed (Day 1) and fasted conditions (Days 3-10).
Effect of food on the pharmacokinetic profile of FOR-6219 and metabolite FOR-6287 based on area under the plasma concentration-time curve (AUC) (Part II).
Measured: Predose and multiple timepoints post-dose in fed (Day 1) and fasted conditions (Days 3-10).
Change in systemic hormone levels (Part III).
Systemic hormones include oestradiol (E2), estrone (E1), luteinizing hormone (LH), follicle stimulating hormone (FSH) and progesterone.
Measured: Days 1, 3, 5, 7, 10, 12 and 14.
Change in endometrial thickness (Part III).
Endometrial thickness will be measured by transvaginal ultrasound.
Measured: Days 3, 7, 10 and 14.
Change in follicle volume (Part III).
Follicle volume will be measured by transvaginal ultrasound.
Measured: Days 3, 7, 10 and 14.

Timeline

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

13 Aug 201811 Nov 2020

First posted17 Oct 2018
Study start13 Aug 2018
Primary completion11 Nov 2020
Study completion11 Nov 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for EndometriosisStudies 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: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03709420
Sponsor's protocol ID: 40-533-001
Status last verified: Nov 2020
First submitted: 8 Oct 2018
Last updated: 18 Nov 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Endometriosis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/Ib, Randomised, Double-blind, Placebo-controlled Study in Healthy Postmenopausal and Pre-menopausal Women to Investigate the Safety, Tolerability, Food Effect, Pharmacokinetics of Single and Multiple Ascending Oral Doses of FOR-6219 and the Pharmacodynamics of Multiple Oral Doses of FOR-6219
ClinicalTrials.gov ID: NCT03709420
Acronym / sponsor ID: 40-533-001
Conditions: Endometriosis
Keywords: Hydroxysteroid (17B) dehydrogenase, HSD17B1
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: Forendo Pharma LtdIndustry (pharma, biotech, devices)
Collaborators: Richmond Pharmacology Limited
Study start: 13 Aug 2018 (actual)
Primary completion: 11 Nov 2020 (actual)
Study completion: 11 Nov 2020 (actual)
First posted: 17 Oct 2018 (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: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboMatching placebo capsule
FOR-6219	Experimental	Drug: FOR-6219Part I (SAD): Single oral doses of 2 mg, 10 mg, 25 mg, 50 mg, 100 mg and 175 mg. Part II (MAD): Multiple oral doses of 50 mg QD, 75 mg BID and 150 mg BID. Part III: Multiple oral doses of 10 mg, 25 mg, 75 mg and 150 mg BID

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Healthy Caucasian female volunteers between 45 and 65 years (inclusive) at screening.
Female volunteers 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.
Volunteers not taking hormone replacement therapy (HRT).
Has a body weight between 50kg and 100kg inclusive and a body mass index (BMI) between 18.0-32.0 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 electrocardiogram (ECG), and clinical laboratory evaluation (haematology, biochemistry, coagulation and urinalysis) that is reasonably likely to interfere with the volunteer's participation in or ability to complete the study as assessed by the investigator.

Key exclusion criteria (53 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 assessments or 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 subject 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 subject at risk because of participation in the study may influence the result of the study, or the subject'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
PlaceboPlacebo capsule to match active drug	Drug	Placebo
FOR-6219FOR-6219 capsule	Drug	FOR-6219

Primary outcome

Safety and tolerability as measured by the incidence of treatment-emergent adverse events (TEAEs).
Time frame: Throughout the study until the follow-up visit, i.e. 7 days after the last dose in Parts I and II and until day 35 in Part III.
All adverse events will be assessed by the investigator and graded for severity according to the criteria from National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) v4.03.
Proportion of subjects with clinically significant changes in laboratory safety tests.
Time frame: Throughout the study until the follow-up visit, i.e. 7 days after the last dose in Parts I and II and until day 35 in Part III.
Laboratory safety tests include haematology, chemistry, coagulation and urinalysis.
Proportion of subjects with changes in vital signs (blood pressure, diastolic blood pressure and pulse)
Time frame: Throughout the study until the follow-up visit, i.e. 7 days after the last dose in Parts I and II and until day 35 in Part III.
Vital signs will be measures using automated monitors in supine position after 5 minute rest.
Proportion of subjects with ECG changes.
Time frame: Throughout the study until the follow-up visit, i.e. 7 days after the last dose in Parts I and II and until day 35 in Part III.
12-lead ECGs and ECG telemetry (only Parts I and II) will be used to measure ECG parameters.
Presence of any pathology in transvaginal ultrasound (Part III).
Time frame: Throughout the study until the day of the last dose (day 14).
Transvaginal ultrasound will be performed at multiple timepoints.

9 secondary outcomes

Maximum observed plasma concentration (Cmax).
Time frame: Pharmacokinetic measures will be taken predose and multiple timepoints postdose after the single dose (SAD) and up to 72 hours after the last dose (Parts II and III).
Area under the plasma concentration-time curve (AUC).
Time frame: Pharmacokinetic measures will be taken predose and multiple timepoints postdose after the single dose (SAD) and up to 72 hours after the last dose (Parts II and III).
Time to maximum plasma concentration (Cmax).
Time frame: Pharmacokinetic measures will be taken predose and multiple timepoints postdose after the single dose (SAD) and up to 72 hours after the last dose (Parts II and III).
Terminal half-life (t½).
Time frame: Pharmacokinetic measures will be taken predose and multiple timepoints postdose after the single dose (SAD) and up to 72 hours after the last dose (Parts II and III).
Effect of food on the pharmacokinetic profile of FOR-6219 and metabolite FOR-6287 based on maximum observed plasma concentration (Cmax) (Part II).
Time frame: Predose and multiple timepoints post-dose in fed (Day 1) and fasted conditions (Days 3-10).
Effect of food on the pharmacokinetic profile of FOR-6219 and metabolite FOR-6287 based on area under the plasma concentration-time curve (AUC) (Part II).
Time frame: Predose and multiple timepoints post-dose in fed (Day 1) and fasted conditions (Days 3-10).
Change in systemic hormone levels (Part III).
Time frame: Days 1, 3, 5, 7, 10, 12 and 14.
Change in endometrial thickness (Part III).
Time frame: Days 3, 7, 10 and 14.
Change in follicle volume (Part III).
Time frame: Days 3, 7, 10 and 14.

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 18 Nov 2020.

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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 in people with Endometriosis, 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 18 inclusion and 53 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 18 Nov 2020. 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. Some participants in this study may receive a placebo. 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?

Safety and tolerability as measured by the incidence of treatment-emergent adverse events (TEAEs). (time frame: Throughout the study until the follow-up visit, i.e. 7 days after the last dose in Parts I and II and until day 35 in Part III.). The study lists 5 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 NCT03709420.

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 18 Nov 2020.