None listed
Conditions
Brief summary
This study is being done to test the safety, tolerability, and how the body processes a new oral drug called FT2109 in older adults. FT2109 is being developed as a potential treatment for inflammatory diseases. The study will look at how the drug behaves in the body after taking a single dose in older adults. The information from this study will help researchers decide if FT2109 is safe enough to be tested in future studies involving people with inflammatory conditions.
Interventions
Geriatric Cohort
Drug Name: FT2109
Dose: Single dose which may be one of: 2 mg, 6 mg, 15 mg, 30 mg, 60 mg, or 100 mg (nominal dose levels; actual doses determined by Safety Review Committee). Specific dose level to be determined based on Part A/B outcomes (not exceeding doses in Part A -ACTRN12625001024437)
Duration: Single dose
Mode of Administration: Oral capsule
Strategies for Monitoring Adherence to the Intervention:
- Drug capsule accountability will be recorded at dispensing and following
Geriatric Cohort Drug Name: FT2109 Dose: Single dose which may be one of: 2 mg, 6 mg, 15 mg, 30 mg, 60 mg, or 100 mg (nominal dose levels; actual doses determined by Safety Review Committee). Specific dose level to be determined based on Part A/B outcomes (not exceeding doses in Part A -ACTRN12625001024437) Duration: Single dose Mode of Administration: Oral capsule Strategies for Monitoring Adherence to the Intervention: - Drug capsule accountability will be recorded at dispensing and following dosing. - Supervised dose administration by trained site staff, including hand and mouth checks following administration which are documented in participant source. - Blood samples are collected for Pharmacokinetic testing
Sponsors
Forward Therapeutics, Pty Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)
Eligibility
Sex/Gender
All
Age
65 Years to 80 Years
Healthy volunteers
Yes
Inclusion 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, 65 to 80 years of age (inclusive) at screening. 3. Well-controlled chronic illnesses such as hypertension, type 2 diabetes, or stable cardiovascular disease, if deemed not to interfere with study outcomes 4. Adequate cognitive function to provide informed consent; absence of advanced dementia. 5. Acceptable organ function as defined by protocol-specified safety laboratory values, including mild or moderate renal, hepatic, or hematologic abnormalities, unless the PI determines that greater impairment poses unacceptable risk. 6. Body mass index (BMI) 18.0 and 32.0 kg/m2, with body weight equal to, or greater than 50.0 kg (males) and equal to, or greater than 45 kg (females) at screening 7. Medically healthy (in the opinion of the PI or delegate), as determined by pre-study medical history, and without clinically significant (CS) abnormalities including the following: a. Physical examination without any clinically relevant findings; b. Systolic blood pressure in the range of 90 to 160 mmHg and diastolic blood pressure in the range of 50 to 95 mmHg after resting for 5 minutes in a supine or semi-supine position. c. Pulse rate in the range of 45 to 100 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 CS abnormalities including QT interval corrected using the Fridericia formula (QTcF) less than 450 msec for males and less than 470 msec for females. f. No CS findings in clinical chemistry, hematology, coagulation, and urinalysis tests. 8. Female volunteers: a. Must be of non-child-bearing 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 9. Male volunteers: a. Must agree not to donate sperm from signing the ICF until at least 97 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 ICF until at least 97 days after the last dose of study drug) c. If engaging in sexual intercourse with a female partner who is not of childbearing potential or a same-sex partner, must agree to use a condom from signing the ICF until at least 97 days after the last dose of study drug. 10. Have suitable venous access for blood sampling. 11. Willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions.
Exclusion criteria
1. Severe frailty, non-ambulatory status, or functional limitations precluding protocol adherence. 2. Active cancer within the last 3–5 years, except for adequately treated skin cancers or in-situ carcinomas. Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma). 3. Known hypersensitivity to the study drug or any of the study drug ingredients. 4. History of anaphylaxis or other significant allergy which, in the opinion of the PI (or delegate), would interfere with the volunteer’s ability to participate in the study. 5. 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 PI (or delegate) to be clinically relevant. Note some stable disease may be acceptable as determined by the PI (or delegate). 6. Previous exposure to any TNF inhibitors or antagonists within 3 months prior to study drug administration. 7. History of surgery or hospitalization within 3 months prior to screening, or surgery planned during the study. 8. Any history of malignant disease in the last 10 years (excludes surgically resected skin squamous cell or basal cell carcinoma). 9. Presence of clinically relevant immunosuppression from, but not limited to, immunodeficiency conditions such as common variable hypogammaglobulinemia. 10. History of risk factors for torsade de pointes (including a family history of long QT syndrome or sudden cardiac death) or a known arrythmia. 11. Presence or having sequelae of gastrointestinal, liver (including Gilbert’s syndrome), kidney, or other conditions known to interfere with the absorption, distribution, metabolism, or excretion of drugs. 12. Liver function test results elevated more 1.5 times than the ULN for gamma glutamyl transferase, bilirubin (total, conjugated and unconjugated), ALP, AST or ALT. Estimated glomerular filtration rate greater than or equal to 60 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (2021). 13. A history of or positive test results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies at the screening visit. 14. Positive drugs of abuse test or alcohol breath test results at the screening visit and/or on admission to the study site on Day 1. 15.Regular consumption of more than 10 standard alcoholic drinks/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% Alc/Vol], 100 mL wine [12% Alc/Vol], or 30 mL spirit [40% Alc/Vol]) and participant is unwilling to abstain from consumption of alcohol for at least 24 hours prior to Day -1 and while confined to the study site. 16. Any use of tobacco containing products and nicotine or nicotine containing products for three months prior to Day -1, and/or the volunteer is unwilling to abstain from smoking or the use of nicotine-containing products for 3 months prior to check-in on Day -1 and throughout the confinement period at the study site and until EoS (non-smokers preferred). 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 CYP3A4/5 enzyme inducer or inhibitor) or 5 half-lives of the medication (whichever is longer) prior to the first dose of study drug. With exception of the use of ibuprofen (up to 1200 mg per day) for no more than 3 consecutive days. Stable medications (taken for at least 3 months) are allowable, with exception of known CYP3A4/5 interactors to be decided on case by case basis to be decided by Sponsor and PI. 19. Consumption of poppy seeds or other products containing poppy seeds within 2 days prior to screening and 2 days prior to check-in on Day -1, consumption of citrus fruits (e.g., Seville orange, grapefruit and similar) or their juices 7 days prior to study drug administration until EoS. Excessive consumption (more than 3 cups per day) of caffeine and/or xanthene products (eg, coffee, tea, chocolate, and caffeine-containing sodas, colas) per day and will abstain from ingesting from 24 hours prior to study drug administration until EoS. 20. Current infection that requires systemically absorbed antibiotic, antifungal, antiparasitic or antiviral medication within 10 days prior to first dose of study drug. 21. History of opportunistic infection(s) (such as: herpes zoster, mycoplasma, Pneumocystis carinii, histoplasma, Aspergillus, mycobacterium) within 6 months prior to screening; 22. Known recurrent or chronic infectious disease(s) history, including but not limited to: chronic kidney infect, chronic chest infection(such as bronchiectasis), nasosinusitis, recurrent urinary tract infection, open, drainage or infected wounds of the skin; 23. Tuberculosis(TB) history, or suspected clinically TB (including but not limited to: pulmonary tuberculosis, lymphoid tuberculosis, tuberculous pleurisy), or a positive Tuberculosis spot test; 24. Use of live (attenuated) vaccinations within 3 months and/or non-live vaccines within 1 month prior to Day -1 or plans to receive these vaccines at any time throughout the trial or 2 weeks after EoS. 25. Donation of blood or plasma within 30 days prior to first dose of study drug, or loss of whole blood of more than 500 mL within 30 days prior to first dose of study drug, or receipt of a blood transfusion within 1 year of the first dose of study drug. 26. Participation in another clinical study of an investigational drug or investigational device 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 PI (or delegate) would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.
Outcome results
None listed