Status and phase
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About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
PART I and II (postmenopausal women):
Inclusion Criteria:
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 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.
Has vital signs consistently outside of the following normal range. Supine blood pressure (after at least 5 minutes of supine rest):
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):
Inclusion Criteria:
Exclusion Criteria:
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):
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.
Primary purpose
Allocation
Interventional model
Masking
87 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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