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

NCT06670950 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-11-01

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Synendos Therapeutics AG

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-30
Primary Completion
2025-05-31
Completion
2025-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06670950 on ClinicalTrials.gov