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 | Completed Phase 1

• 2 other identifiers: SYN510CT021010456
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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

Study Arms (2)

Part 1: Relative bioavailability and food effect

EXPERIMENTAL

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

Part 2: Multiple Ascending Dose

EXPERIMENTAL

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; Drug: Placebo

Interventions

Placebo DRUG

Oral formulation

Part 2: Multiple Ascending Dose

SYT-510 DRUG

Oral formulation A fasted

Part 1: Relative bioavailability and food effect; Part 2: Multiple Ascending Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Male and female participants of non-childbearing potential
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synendos Therapeutics AG: lead

Study Sites (1)

Richmond Pharmacology Ltd

London, United Kingdom

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 1, 2024
• Study Start: November 4, 2024
• Primary Completion: May 17, 2025
• Study Completion: May 23, 2025
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)