None listed
Conditions
Brief summary
This study is being done to test the safety and tolerability of a new oral drug called FT2109 and to assess how the body processes FT2109 and a formulated FT2109 capsule compared with the API capsule in healthy participants. FT2109 is being developed as a potential treatment for inflammatory diseases. The study will examine how the drug behaves in the body after single oral doses of two different capsule formulations. The information from this study will help researchers determine whether FT2109 is safe and how it is absorbed compared with the reference formulation. Results will support further development of FT2109 for use in people with inflammatory conditions.
Interventions
Participants will receive a single dose of each formulation in a cross-over design, with a 10-day washout period between administrations (Day 1 and Day 12)
FT2109 Active Pharmaceutical Ingredient (API) capsules will be administered at a dose of 50 mg. Participants will receive a single 50 mg dose of FT2109 API capsule on Day 1 and a single 50 mg dose of FT2109 formulated capsule on Day 12.
Mode of administration: Oral capsule.
Strategies for monitoring adherence to the intervention:
-Drug cap
Participants will receive a single dose of each formulation in a cross-over design, with a 10-day washout period between administrations (Day 1 and Day 12) FT2109 Active Pharmaceutical Ingredient (API) capsules will be administered at a dose of 50 mg. Participants will receive a single 50 mg dose of FT2109 API capsule on Day 1 and a single 50 mg dose of FT2109 formulated capsule on Day 12. Mode of administration: Oral capsule. Strategies for monitoring adherence to the intervention: -Drug capsule accountability will be recorded at dispensing and following dosing. -Doses will be administered under supervision by trained site staff, including hand and mouth checks following administration, documented in participant source records. -Blood samples will be collected for pharmacokinetic analysis.
Sponsors
Forward Therapeutics Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Volunteers will be included in the study only if they satisfy all of the following criteria: 1. Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects. 2. Adult males and females, 18 to 55 years of age (inclusive) at screening. 3. Body mass index (BMI) greater than or equal to 18.0 and less than or equal to 32.0 kg/m², and body weight greater than or equal to 50.0 kg (males) and greater than or equal to 45 kg (females) at screening. 4. Medically healthy (in the opinion of the PI or delegate), as determined by pre-study medical history, and without clinically significant abnormalities including the following: a. Physical examination without any clinically relevant findings. b. Systolic blood pressure in the range of 90 to 150 mmHg and diastolic blood pressure in the range of 40 to 90 mmHg after resting for 5 minutes in a supine or semi-supine position. c. Pulse rate in the range of 40 to 100 beats per minute (bpm) after 5 minutes resting in a supine or semi-supine position. d. Body temperature (tympanic), between 35.5°C and 37.7°C. e. Electrocardiogram without clinically significant abnormalities including QTcF less than 450 msec for males and less than 470 msec for females. f. No clinically significant findings in clinical chemistry, hematology, coagulation, and urinalysis tests. 5. Female volunteers: a. Must be of non-childbearing potential i.e., surgically sterilized (hysterectomy, bilateral salpingectomy, bilateral oophorectomy) at least 6 weeks before the screening visit or postmenopausal (where postmenopausal is defined as no menses for 12 months without an alternative medical cause and a follicle-stimulating hormone [FSH] level consistent with postmenopausal status, per local laboratory guidelines), or b. If of childbearing potential, must: i. Have a negative pregnancy test at the screening visit and on admission to the study site on Day -1. ii. Agree not to attempt to become pregnant or donate ova from signing the informed consent form until at least 30 days after the last dose of study drug. iii. Agree to use adequate contraception (defined as use of a condom by the male partner combined with use of a highly effective method of contraception) from signing the informed consent form until at least 30 days after the last dose of study drug, if not exclusively in a same-sex relationship or abstinent as a committed lifestyle. 6. Male volunteers: a. Must agree not to donate sperm from signing the informed consent form until at least 90 days after the last dose of study drug. b. If engaging in sexual intercourse with a female partner who could become pregnant, must agree to use adequate contraception (defined as use of a condom combined with use of a highly effective method of contraception) from signing the informed consent form until at least 90 days after the last dose of study drug. c. If engaging in sexual intercourse with a female partner who is not of childbearing potential, must agree to use a condom from signing the informed consent form until at least 90 days after the last dose of study drug. 7. Have suitable venous access for blood sampling. 8. Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Exclusion criteria
Volunteers will be excluded from the study if they meet any of the following criteria: 1. Known hypersensitivity to the study drug or any of the study drug ingredients. 2. History of anaphylaxis or other significant allergy which, in the opinion of the Principal Investigator (or delegate), would interfere with the volunteer’s ability to participate in the study. 3. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, psychiatric, or neurological disease/disorder, including any acute illness within the past 3 months, determined by the Principal Investigator (or delegate) to be clinically relevant. 4. Previous exposure to any tumour necrosis factor (TNF) inhibitors or antagonists within 3 months prior to study drug administration. 5. History of surgery or hospitalisation within 3 months prior to screening, or surgery planned during the study. 6. Any history of malignant disease in the last 10 years (excluding surgically resected skin squamous cell or basal cell carcinoma). 7. Presence of clinically relevant immunosuppression, including immunodeficiency conditions such as common variable hypogammaglobulinemia. 8. History of risk factors for torsade de pointes (including family history of long QT syndrome or sudden cardiac death) or known arrhythmia. 9. Presence or sequelae of gastrointestinal, liver (including Gilbert’s syndrome), kidney, or other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs. 10. Liver function test results elevated more than 1.5 times the upper limit of normal for gamma glutamyl transferase, bilirubin (total, conjugated and unconjugated), alkaline phosphatase, aspartate aminotransferase, or alanine aminotransferase. 11. Estimated glomerular filtration rate less than 80 mL/min/1.73 m² using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (2021). 12. History of or positive test results for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus antibodies at the screening visit. 13. Positive drugs of abuse test, carbon monoxide breath test, or alcohol breath test at the screening visit and/or on admission to the study site on Day -1. 14. Regular consumption of more than 10 standard alcoholic drinks per week and/or more than 4 standard alcoholic drinks on any one day (where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer [4.9% alcohol/volume], 100 mL wine [12% alcohol/volume], or 30 mL spirit [40% alcohol/volume]) and unwillingness to abstain from alcohol for at least 24 hours prior to Day -1 and while confined to the study site. 15. Any use of tobacco-containing products or nicotine-containing products within 3 months prior to Day -1, and/or unwillingness to abstain from smoking or nicotine use for 3 months prior to check-in on Day -1 and throughout the confinement period at the study site and until end of study (non-smokers preferred). 16. Females who are breastfeeding or planning to breastfeed. 17. Unable to swallow oral medication. 18. Use of any prescription or over-the-counter medication (including herbal products, diet aids, vitamins, and hormone supplements) within 7 days (or 14 days if the drug is a potential cytochrome P450 3A4/5 enzyme inducer or inhibitor) or 5 half-lives of the medication (whichever is longer) prior to first dose of study drug, except for ibuprofen (up to 1200 mg per day) or paracetamol (up to 2 g per day) for no more than 3 consecutive days. 19. Consumption of poppy seeds or products containing poppy seeds within 2 days prior to screening and 2 days prior to check-in on Day -1; consumption of Seville orange, grapefruit, or their juices within 7 days prior to study drug administration until end of study. Excessive caffeine or xanthene intake (more than 3 cups per day of coffee, tea, chocolate, or caffeine-containing beverages) with abstinence required from 24 hours prior to study drug administration and during confinement. 20. Current infection requiring systemically absorbed antibiotic, antifungal, antiparasitic, or antiviral medication within 10 days prior to first dose of study drug. 21. History of opportunistic infections (such as herpes zoster, mycoplasma, Pneumocystis jirovecii, histoplasma, Aspergillus, or Mycobacterium) within 6 months prior to screening. 22. Known recurrent or chronic infectious disease history, including but not limited to chronic kidney infection, chronic chest infection (such as bronchiectasis), nasosinusitis, recurrent urinary tract infection, or open, draining, or infected skin wounds. 23. Tuberculosis history or suspected clinically active tuberculosis (including pulmonary, lymphoid, or pleural tuberculosis), or a positive tuberculosis spot test. 24. Use of live (attenuated) vaccines within 3 months and/or non-live vaccines within 1 month prior to Day -1, or plans to receive such vaccines during the trial or within 2 weeks after end of study. 25. Donation of blood or plasma within 30 days prior to first dose of study drug, loss of more than 500 mL of whole blood within 30 days prior to first dose, or receipt of a blood transfusion within 1 year prior to first dose. 26. Receipt of an investigational drug or use of an investigational device in another clinical study within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to screening. 27. Any other condition or prior therapy that, in the opinion of the Principal Investigator (or delegate), would make the volunteer unsuitable for this study, including inability to cooperate fully with study requirements or likelihood of noncompliance with study procedures.
Outcome results
None listed