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
- Registration Number
- NCT06670950
- Lead Sponsor
- Synendos Therapeutics AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Part 1: Relative bioavailability and food effect SYT-510 Randomised, open label, single-dose, three period, three-sequence crossover study to evaluate the relative bioavailability (rBA) of a new oral formulation of SYT-510 under fasting conditions and the effect of food in healthy participants. Part 2: Multiple Ascending Dose SYT-510 Randomised, double-blind, placebo-controlled multiple ascending dose (MAD) study in healthy participants to assess the safety, tolerability and pharmacokinetics (PK) of SYT-510 after repeated administrations. Part 2: Multiple Ascending Dose Placebo Randomised, double-blind, placebo-controlled multiple ascending dose (MAD) study in healthy participants to assess the safety, tolerability and pharmacokinetics (PK) of SYT-510 after repeated administrations.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (1)
Richmond Pharmacology Ltd
🇬🇧London, United Kingdom