Healthy
Conditions
Brief 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.
Interventions
DRUGSYT-510
Oral formulation A fasted
DRUGPlacebo
Oral formulation
Sponsors
Synendos Therapeutics AG
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Maximum Observed Concentration (Cmax) of SYT-510 | 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 | Up to 72 hours post-dose |
| Part 1: AUC of SYT-510 | 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 | Up to Day 20 |
Secondary
| Measure | Time frame |
|---|---|
| Part 1: Incidence and severity of treatment related adverse event, including abnormal laboratory events to evaluate the safety and tolerability profile of single doses of SYT-510 | Up to Day 4 |
| Part 2: Maximum observed concentration (Cmax) of SYT-510 | Up to Day 14 |
| Part 2: Time of maximal plasma concentration (tmax) of SYT-510 | Up to Day 14 |
| Part 2: AUCtau of SYT-510 | Up to Day 14 |
| Part 2: Terminal elimination half-life (t1/2) of SYT-510 | Up to several days post last dose |
| Part 2: Accumulation ratio of SYT-510 | Up to Day 14 |
Countries
United Kingdom
Outcome results
None listed