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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Drug: SYT-510; Drug: SYT-510; Drug: SYT-510; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Synendos Therapeutics AG; Phone Number: +41783008789; Email: info@synendos.com

Study Locations

• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Richmond Pharmacology Ltd
    • Contact: Principal Investigator; Phone Number: +44 2070425800; Email: do@richmondpharmacology.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Relative bioavailability and food effect; Randomised, open label, single-dose, three period, three-sequence crossover study to evaluate the relative bioavailability (rBA) of a new oral formulation of SYT-510 under fasting conditions and the effect of food in healthy participants.	Drug: SYT-510; Oral formulation A fasted; Drug: SYT-510; Oral formulation B fasted; Drug: SYT-510; Oral formulation A fed
Experimental: Part 2: Multiple Ascending Dose; Randomised, double-blind, placebo-controlled multiple ascending dose (MAD) study in healthy participants to assess the safety, tolerability and pharmacokinetics (PK) of SYT-510 after repeated administrations.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Part 1: Maximum Observed Concentration (Cmax) of SYT-510	Up to 72 hours post-dose
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	Up to 72 hours post-dose
Part 1: AUC of SYT-510	Up to several days post last dose
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	Up to Day 20

Secondary Outcome Measures

Outcome Measure	Time Frame
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	Up to Day 4
Part 2: Maximum observed concentration (Cmax) of SYT-510	Up to Day 14
Part 2: Time of maximal plasma concentration (tmax) of SYT-510	Up to Day 14
Part 2: AUCtau of SYT-510	Up to Day 14
Part 2: Terminal elimination half-life (t1/2) of SYT-510	Up to several days post last dose
Part 2: Accumulation ratio of SYT-510	Up to Day 14

Collaborators and Investigators

• Sponsor: Synendos Therapeutics AG

Study record dates

Study Major Dates

• Study Start (Estimated): October 30, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: October 31, 2024
• First Posted (Estimated): November 1, 2024

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: SYN510CT02; 1010456 (Registry Identifier: IRAS ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No