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Completed
NCT06670950
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
Conditions: Healthy
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 28
Sponsor: Synendos Therapeutics AG
Location: Richmond Pharmacology Ltd London
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 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.
Source: ClinicalTrials.gov (NCT06670950). StuddyBuddy aggregates publicly available trial information.