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RECRUITING
NCT06670950
PHASE1

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

View on ClinicalTrials.gov

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

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

Locations (1)

Richmond Pharmacology Ltd

London, United Kingdom