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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Synendos Therapeutics AG · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	SYT-510	Oral formulation A fasted
DRUG	SYT-510	Oral formulation B fasted
DRUG	SYT-510	Oral formulation A fed
DRUG	Placebo	Oral formulation

Timeline

• Start date: 2024-10-30
• Primary completion: 2025-05-31
• Completion: 2025-05-31
• First posted: 2024-11-01
• Last updated: 2024-11-01

Locations

1 site across 1 country: United Kingdom