Testing the safety and effects of SUL-238 in healthy adults

A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics of Single and Multiple Ascending Oral Doses of SUL-238 in Healthy Subjects

This study is testing the safety and effects of a new oral medication called SUL-238 in healthy adults aged 40 and older to see how it works in the body.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 83 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: GEN İlaç ve Sağlık Ürünleri A.Ş. (industry)
• Locations: 1 site (Kayseri)
• Trial ID: NCT06277492 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of the oral medication SUL-238 in healthy subjects aged 40 and older. The study consists of four parts, with the first part focusing on single ascending doses of SUL-238, where various doses will be administered to participants to monitor for any adverse effects. If no adverse events are observed, the dose will be escalated to determine the maximum tolerated dose. The study aims to gather important data on how the drug behaves in the body and its safety profile.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy men and women aged 40 years and older.

Not a fit: Patients who are not healthy or those under 40 years of age may not receive any benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and dosing of SUL-238, potentially leading to its use in treating various conditions.

How similar studies have performed: Other studies involving similar first-in-human approaches have shown promise, but this specific drug and its dosing regimen are novel.

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.

Where this trial is running

Kayseri

• Erciyes University IKUM Center — Kayseri, Turkey (RECRUITING)

Study contacts

• Principal investigator: Zafer Sezer, MD — Department of Pharmacology, Faculty of Medicine, Erciyes University
• Study coordinator: Nadir Ulu, MD, PhD

Conditions: Healthy Subjects, SUL-238, Oral, Safety, Pharmacokinetics, Food effect