Assessing the effects of SYT-510 in healthy participants
A Two-Part Study Investigating the Relative Bioavailability and the Potential Food Effect After a Single Oral Dose Administration of a New Formulation of SYT-510, and the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Oral Dose Administration of SYT-510 in Healthy Subjects
This study tests a new medication called SYT-510 in healthy people to see how well it's absorbed by the body and how it interacts with food, while also checking for safety and side effects.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Synendos Therapeutics AG Industry-sponsored |
| Locations | 1 site (London) |
| Trial ID | NCT06670950 on ClinicalTrials.gov |
What this trial studies
This study investigates the bioavailability and food effects of SYT-510, a new formulation, in healthy individuals. It consists of two parts: the first part evaluates the relative bioavailability and food effects after a single dose, while the second part assesses the safety, tolerability, and pharmacokinetics of multiple doses. Participants will receive either SYT-510 or a placebo, and the findings will help determine appropriate dosing for future studies.
Who should consider this trial
Good fit: Ideal candidates are healthy males and females aged 18 to 65 with a BMI between 18 and 30 kg/m2.
Not a fit: Patients with current diseases or significant health issues that could interfere with the study will not benefit from participation.
Why it matters
Potential benefit: If successful, this study could lead to a better understanding of SYT-510's effects, potentially paving the way for its use in future therapeutic applications.
How similar studies have performed: While this approach is common in early-phase drug development, the specific formulation and its effects are novel and have not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Males or females of non-childbearing potential (WOCBP) aged 18 to 65 years old (inclusive) at the date of signing the informed consent form (ICF). * Normal ECG, showing no clinically relevant deviations, as judged by the investigator. * Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at Screening and Admission (e.g Day -1 or Day -2) and a minimum weight of 50kg. Exclusion Criteria: * Current or recurrent disease that as judged by the Investigator may interfere with the execution of the conduct of the study. * Laboratory parameters outside of the laboratory normal range. * Positive test results for alcohol or drugs of abuse. * Treatment with an investigational drug within 90 days preceding the first dose of trial medication. * Known or suspected intolerance or hypersensitivity to the investigational product, any closely related compound, or any of the stated ingredients. * History of significant allergic reactions (anaphylaxis, angioedema) to any product (food, pharmaceutical, etc). * Current smokers and those who have smoked within the last 6 months.
Where this trial is running
London
- Richmond Pharmacology Ltd — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Synendos Therapeutics AG
- Email: info@synendos.com
- Phone: +41783008789
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.