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
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
Synendos Therapeutics AG
90 participants
Oct 30, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- 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 Criteria7
- 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.
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Interventions
Oral formulation A fasted
Oral formulation B fasted
Oral formulation A fed
Oral formulation
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06670950