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Completed

NCT Number: 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

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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Richmond Pharmacology Ltd

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SYT-510

Drug

Oral formulation A fasted

Placebo

Drug

Oral formulation

Primary outcomes

  1. Part 1: Maximum Observed Concentration (Cmax) of SYT-510

    Time frame: Up to 72 hours post-dose

  2. Part 1: Area under the concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC0-tlast) of SYT-510

    Time frame: Up to 72 hours post-dose

  3. Part 1: AUC of SYT-510

    Time frame: Up to several days post last dose

  4. Part 2: Incidence and severity of treatment related adverse event, including abnormal laboratory events to evaluate the safety and tolerability profile of multiple ascending doses of SYT-510

    Time frame: Up to Day 20

Secondary outcomes

  1. Part 1: Incidence and severity of treatment related adverse event, including abnormal laboratory events to evaluate the safety and tolerability profile of single doses of SYT-510

    Time frame: Up to Day 4

  2. Part 2: Maximum observed concentration (Cmax) of SYT-510

    Time frame: Up to Day 14

  3. Part 2: Time of maximal plasma concentration (tmax) of SYT-510

    Time frame: Up to Day 14

  4. Part 2: AUCtau of SYT-510

    Time frame: Up to Day 14

  5. Part 2: Terminal elimination half-life (t1/2) of SYT-510

    Time frame: Up to several days post last dose

  6. Part 2: Accumulation ratio of SYT-510

    Time frame: Up to Day 14

Sponsors and collaborators

Lead sponsor

Synendos Therapeutics AG

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 1, 2024
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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