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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
Sponsor: Synendos Therapeutics AG
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.
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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-10-30
Completion Date
2025-05-31
Last Updated
2024-11-01
Healthy Volunteers
Yes
Conditions
Interventions
SYT-510
Oral formulation A fasted
SYT-510
Oral formulation B fasted
SYT-510
Oral formulation A fed
Placebo
Oral formulation
Locations (1)
Richmond Pharmacology Ltd
London, United Kingdom