CompletedPhase 1

A Phase 1 Single Dose and Multiple Ascending Dose Study to Assess the Relative Bioavailability, Food Effect, Safety, Tolerability and Pharmacokinetics of SYT-510 in Healthy Participants

United Kingdom28 participantsStarted 2024-11-04

Plain-language summary

Part 1 aims to investigate the relative bioavailability of a new formulation and to assess potential food effects following oral administration of SYT-510. Part 1 will then guide dosing in Part 2, a multiple dose study which aims to assess safety, tolerability and pharmacokinetic of multiple SYT-510 administrations.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part 1: Maximum Observed Concentration (Cmax) of SYT-510

Timeframe: Up to 72 hours post-dose

Part 1: Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of SYT-510

Timeframe: Up to 72 hours post-dose

Part 1: AUC of SYT-510

Timeframe: Up to several days post last dose

Part 2: Incidence and severity of treatment related adverse event, including abnormal laboratory events to evaluate the safety and tolerability profile of multiple ascending doses of SYT-510

Timeframe: Up to Day 20

Trial details

NCT IDNCT06670950

SponsorSynendos Therapeutics AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-17

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part 1: Maximum Observed Concentration (Cmax) of SYT-510

Timeframe: Up to 72 hours post-dose

Part 1: Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of SYT-510

Timeframe: Up to 72 hours post-dose

Part 1: AUC of SYT-510

Timeframe: Up to several days post last dose

Part 2: Incidence and severity of treatment related adverse event, including abnormal laboratory events to evaluate the safety and tolerability profile of multiple ascending doses of SYT-510

Timeframe: Up to Day 20