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Study finishedPhase1

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

NCT ID: NCT06670950

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
SYT-510 (drug), SYT-510 (drug), SYT-510 (drug), Placebo (drug)
How long the study runs
Study runs about 6 months (dates as stated)
About the drug or intervention
SYT-510 — drug: Oral formulation A fasted · SYT-510 — drug: Oral formulation B fasted · SYT-510 — drug: Oral formulation A fed · Placebo — drug: Oral formulation
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years to 65 Years
Who
All
Number of participants
28
Started
2024-11-04
Last checked
2026-06

Plain English Summary

What is this study?

  • • Testing a new treatment for healthy
  • • Phase1 - 28 participants
  • • Part 1 aims to investigate the relative bioavailability of a new formulation and to assess potential food effects following oral administration of SYT-510

Who can take part?

  • • Ages 18 Years to 65 Years
  • • Diagnosed with healthy

Where?

  • • London - Richmond Pharmacology Ltd

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Healthy

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years - 65 Years
  • Who can join: All genders

What the study is looking for

  • ✓Males or females of non-childbearing potential (WOCBP) aged 18 to 65 years old (inclusive) at the date of signing...
  • ✓Normal ECG, showing no clinically relevant deviations, as judged by the investigator.
  • ✓Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at Screening and Admission (e.g Day -1 or Day -2) and a...

Who cannot take part

  • ✗Current or recurrent disease that as judged by the Investigator may interfere with the execution of the conduct of...
  • ✗Laboratory parameters outside of the laboratory normal range.
  • ✗Positive test results for alcohol or drugs of abuse.
  • ✗Treatment with an investigational drug within 90 days preceding the first dose of trial medication.
  • ✗Known or suspected intolerance or hypersensitivity to the the the study treatment, any closely related compound, or...
See the full criteria
Inclusion Criteria: * Males or females of non-childbearing potential (WOCBP) aged 18 to 65 years old (inclusive) at the date of signing the informed consent form (ICF). * Normal ECG, showing no clinically relevant deviations, as judged by the investigator. * Body mass index (BMI) between 18 and 30 kg/m2, inclusive, at Screening and Admission (e.g Day -1 or Day -2) and a minimum weight of 50kg. Exclusion Criteria: * Current or recurrent disease that as judged by the Investigator may interfere with the execution of the conduct of the study. * Laboratory parameters outside of the laboratory normal range. * Positive test results for alcohol or drugs of abuse. * Treatment with an investigational drug within 90 days preceding the first dose of trial medication. * Known or suspected intolerance or hypersensitivity to the investigational product, any closely related compound, or any of the stated ingredients. * History of significant allergic reactions (anaphylaxis, angioedema) to any product (food, pharmaceutical, etc). * Current smokers and those who have smoked within the last 6 months.

Where Is This Study? (1 UK site)

Richmond Pharmacology Ltd

London, United Kingdom

Data sourced from ClinicalTrials.gov · Last verified: 2026-06