HealthyPhase 1NCT06670950
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 Phase 1 study testing SYT-510 in people with Healthy, run by Synendos Therapeutics AG at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- SYT-510
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Nov 2024to 23 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- SYT-510, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYT-510Drug
Oral formulation A fasted
SYT-510Drug
Oral formulation B fasted
SYT-510Drug
Oral formulation A fed
PlaceboDrug
Oral formulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: SYT-510; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Maximum Observed Concentration (Cmax) of SYT-510
Measured: 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
Measured: Up to 72 hours post-dose
Part 1: AUC of SYT-510
Measured: 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
Measured: 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
Measured: Up to Day 4
Part 2: Maximum observed concentration (Cmax) of SYT-510
Measured: Up to Day 14
Part 2: Time of maximal plasma concentration (tmax) of SYT-510
Measured: Up to Day 14
Part 2: AUCtau of SYT-510
Measured: Up to Day 14
Part 2: Terminal elimination half-life (t1/2) of SYT-510
Measured: Up to several days post last dose
Part 2: Accumulation ratio of SYT-510
Measured: Up to Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start4 Nov 2024
- Primary completion17 May 2025
- Study completion23 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synendos Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670950
- Sponsor's protocol ID
- SYN510CT02
- Other IDs
- 1010456
- Status last verified
- Jun 2026
- First submitted
- 29 Oct 2024
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06670950
- Acronym / sponsor ID
- SYN510CT02
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Synendos Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2024 (actual)
- Primary completion
- 17 May 2025 (actual)
- Study completion
- 23 May 2025 (actual)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: Relative bioavailability and food effect | Experimental | Drug: SYT-510Randomised, 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. |
| Part 2: Multiple Ascending Dose | Experimental | Drug: SYT-510, Drug: PlaceboRandomised, 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SYT-510Oral formulation A fasted | Drug | Part 1: Relative bioavailability and food effect, Part 2: Multiple Ascending Dose |
| SYT-510Oral formulation B fasted | Drug | Part 1: Relative bioavailability and food effect |
| SYT-510Oral formulation A fed | Drug | Part 1: Relative bioavailability and food effect |
| PlaceboOral formulation | Drug | Part 2: Multiple Ascending Dose |
Primary outcome
Part 1: Maximum Observed Concentration (Cmax) of SYT-510
Time frame: 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
Time frame: Up to 72 hours post-dose
Part 1: AUC of SYT-510
Time frame: 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
Time frame: Up to Day 20
6 secondary outcomes
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
Part 2: Maximum observed concentration (Cmax) of SYT-510
Time frame: Up to Day 14
Part 2: Time of maximal plasma concentration (tmax) of SYT-510
Time frame: Up to Day 14
Part 2: AUCtau of SYT-510
Time frame: Up to Day 14
Part 2: Terminal elimination half-life (t1/2) of SYT-510
Time frame: Up to several days post last dose
Part 2: Accumulation ratio of SYT-510
Time frame: Up to Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYT-510 in people with Healthy, run by Synendos Therapeutics AG at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Maximum Observed Concentration (Cmax) of SYT-510 (time frame: Up to 72 hours post-dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026.