A First-In-Human Study of Single and Multiple Ascending Doses of Oral SUL-238 in Healthy Subjects

Launched by GEN İLAÇ VE SAĞLIK ÜRÜNLERI A.Ş. · Feb 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called SUL-238 to see how safe it is and how the body processes it when taken in different doses by healthy adults aged 40 and older. The study is designed to compare the effects of the medication with a placebo, which is an inactive substance, to ensure that any effects observed are due to the medication itself. The trial is currently looking for participants who are in good health, have a stable medical history, and meet specific criteria, such as having a body weight over 50 kg and a normal body mass index.

If you decide to participate, you will undergo several evaluations to confirm your health status, including medical history checks, physical exams, and lab tests. Throughout the study, participants will take the medication or placebo and will be closely monitored for any side effects or reactions. This trial aims to gather important information that could help in developing this new treatment for future use, so your involvement could contribute significantly to medical research.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy as determined by the Investigator, based on a medical evaluation including medical history, physical examination, neurological examination, laboratory tests and cardiac monitoring.
• • 2. Men and women aged≥40 years at Screening.
• • 3. Subject must understand the nature of the study and provide signed and dated written informed consent in accordance with local regulations before the conduct of any study-related procedures.
• • 4. Able to complete all study related testing and evaluations.
• • 5. Women and men of child-bearing potential with partners of child-bearing potential must agree to use highly effective contraception. For male subjects, contraception should continue for 90 days after the last dose of investigational medicinal product (IMP, one spermatic cycle).
• • 6. Women of non-childbearing potential must be post-menopausal (the last menstrual period was at least 12 months ago, and follicle-stimulating hormone \[FSH\] at Screening confirms post-menopausal status), or have no uterus, ovaries, or fallopian tubes (or have their fallopian tubes tied). All women must have a negative pregnancy test result before administration of test article. Women who are surgically sterile must provide documentation of the procedure by an operative report or by ultrasound.
• • 7. Body weight \> 50 kg for men and \> 50 kg for women and Body Mass Index (BMI) within the range 18.5-30.0 kg/m2, inclusive.
• • 8. Subject must be, in the opinion of the Investigator, able to participate in all scheduled evaluations, likely to complete all required tests, and likely to be compliant.
• Exclusion Criteria:
• • 1. A positive urine drug screen/alcohol breath test at Screening or Day -1.
• • 2. Any history of intellectual disability or psychiatric disorders, including substance use disorders, according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria, except a history of mild depression/anxiety that has been resolved for at least the past 12 months.
• • 3. A positive Hepatitis B surface antigen, Hepatitis C antibody, or Human Immunodeficiency Virus (HIV) antibody test at Screening.
• • 4. Alanine aminotransferase or aspartate aminotransferase levels greater than 1.5 times the upper limit of normal (ULN) at Screening or between Screening and first dose administration.
• • 5. History of regular alcohol consumption within the last 12 months, defined as an average weekly intake of \>21 alcoholic drinks/week for men or \>14 alcoholic drinks/week for women.
• • 6. Regularly consumed (e.g., more days than not) excessive quantities of xanthine-containing beverages (e.g., more than five cups of coffee or the equivalent per day) within 30 days prior to Day -1.
• • 7. Received or used an investigational product (including placebo) or device within the following time period prior to Day -1 in the current study: 90 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).
• • 8. Use of prescription or non-prescription drugs, vitamins, herbal, and dietary supplements within 7 days (or 28 days if the drug is a potential hepatic enzyme inducer) or 5 half-lives (whichever is longer) prior to Day -1.
• • 9. History of clinically significant sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the Investigator or Medical Monitor, contraindicates their participation.
• • 10. A positive serum pregnancy test or lactation.
• • 11. A history or presence of any disease, condition, or surgery likely to affect drug absorption, distribution, metabolism, or excretion. Subjects with a history of cholecystectomy should be excluded.
• • 12. A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, pulmonary, ophthalmologic, immunologic, hematologic, dermatologic, or neurologic abnormality.
• • 13. Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, in the judgement of the Investigator or Medical Monitor, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy.
• • 14. A clinically significant vital signs abnormality at Screening or Day -1 This includes, but is not limited to, the following, in the sitting position (3 measurements, each 5 minutes apart): (a) systolic blood pressure \< 90 or \>140 mmHg, (b) diastolic blood pressure \< 50 or \> 95 mmHg, or (c) heart rate \< 45 or \> 100 beats per minute.
• • 15. Subjects who have previously been enrolled in this study.
• • 16. The subject is, in the opinion of the Investigator or Medical Monitor, unlikely to comply with the protocol or is unsuitable for any reason, e.g., known issues with ability to swallow tablets.