Clinical trial 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
Official title: A Two-Part Study Investigating the Relative Bioavailability and the Potential Food Effect After a Single Oral Dose Administration of a New Formulation of SYT-510, and the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Oral Dose Administration of SYT-510 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Synendos Therapeutics AG
Sponsor class: INDUSTRY
First posted: 2024-11-01
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Part 1: Maximum Observed Concentration (Cmax) of SYT-510
timeFrame: Up to 72 hours post-dose
measure: 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
timeFrame: Up to 72 hours post-dose
measure: Part 1: AUC of SYT-510
timeFrame: Up to several days post last dose
measure: 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
timeFrame: Up to Day 20
Secondary outcomes:
measure: 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
timeFrame: Up to Day 4
measure: Part 2: Maximum observed concentration (Cmax) of SYT-510
timeFrame: Up to Day 14
measure: Part 2: Time of maximal plasma concentration (tmax) of SYT-510
timeFrame: Up to Day 14
measure: Part 2: AUCtau of SYT-510
timeFrame: Up to Day 14
measure: Part 2: Terminal elimination half-life (t1/2) of SYT-510
timeFrame: Up to several days post last dose
measure: Part 2: Accumulation ratio of SYT-510
timeFrame: Up to Day 14
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Richmond Pharmacology Ltd
Study officials:
References: