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

Synendos Therapeutics AG

Status and phase: Enrolling; Phase 1

Conditions: Healthy

Treatments: Drug: SYT-510; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06670950

1010456 (Registry Identifier)

SYN510CT02

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

90 participants in 2 patient groups

Part 1: Relative bioavailability and food effect

Experimental group

Description:

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.

Treatment:

Drug: SYT-510

Drug: SYT-510

Drug: SYT-510

Part 2: Multiple Ascending Dose

Experimental group

Description:

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.

Treatment:

Drug: SYT-510

Drug: Placebo

Drug: SYT-510

Drug: SYT-510