Actively Recruiting
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
Led by Synendos Therapeutics AG · Updated on 2024-11-01
90
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females of non-childbearing potential aged 18 to 65 years at informed consent
- Normal ECG with no clinically relevant deviations
- Body mass index between 18 and 30 kg/m2 and minimum weight of 50 kg
You will not qualify if you...
- Current or recurrent diseases that may interfere with study conduct
- Laboratory test results outside normal range
- Positive tests for alcohol or drugs of abuse
- Use of investigational drug within 90 days before study drug
- Known or suspected intolerance or hypersensitivity to SYT-510 or related compounds
- History of severe allergic reactions such as anaphylaxis or angioedema
- Current smokers or those who smoked within the last 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Richmond Pharmacology Ltd
London, United Kingdom
Actively Recruiting
Research Team
S
Synendos Therapeutics AG
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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