Overview
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 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.