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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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06670950). StuddyBuddy aggregates publicly available trial information.