Healthy VolunteersPhase 1NCT07811063
A Study to Test a Single Dose of a New Tablet Formulation of TRTL-729
A Phase 1 study testing TRTL-729 in people with Healthy Volunteers, run by Tortugas Neuroscience, Inc. at 1 site in New Zealand.
Trial summary
This study assesses the safety, tolerability, and pharmacokinetics (PK) of the tablet formulation of TRTL-729 in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- TRTL-729
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNew Zealand
- Study dates
- 28 Sep 2026to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Generally healthy, ambulatory male or female adults aged 18 to 55 years, as determined by the investigator.
- Able and willing to provide written informed consent and comply with all study procedures and the visit schedule.
- Body Mass Index (BMI) 18.0 to 32.0 kilograms per meter square kg/m^2 and body weight greater than (>)50 kilograms (kg).
- Clinically acceptable medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG), as determined by the investigator.
- QT interval Corrected using Fridericia's Formula (QTcF) lesser than or equal to (≤)450 milliseconds (msec) for males or ≤470 msec for females.
- Nonsmokers or light smokers (less than [<]10 cigarettes/week or equivalent vaping) for at least 3 months before dosing and willing to abstain during confinement.
- Females must be of nonchildbearing potential or, if of childbearing potential, must have a negative pregnancy test and agree to use highly effective contraception throughout the required study period.
- Male participants must agree to use appropriate contraception and refrain from sperm donation for the required study period.
Who cannot join
- Any clinically significant acute or chronic medical condition that, in the investigator's opinion, could affect participant safety or study assessments.
- History of seizures, epilepsy, significant head injury associated with loss of consciousness, family history of seizures or epilepsy, or other conditions or medications that increase seizure risk.
- Clinically significant cardiovascular, cerebrovascular, or peripheral vascular disease, clinically significant ECG abnormalities, torsade de pointes, or a family history of long QT syndrome or sudden cardiac death.
- Active infection or clinically significant recent illness before screening or dosing.
- Positive test for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C.
- Clinically significant hepatic or renal impairment or clinically significant laboratory abnormalities.
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- History of malignancy within the past 10 years (except adequately treated nonmetastatic basal cell or squamous cell skin cancer or cervical carcinoma in situ).
- Current or recent substance or alcohol use disorder, or positive drug or alcohol screening.
- Current or history of clinically significant psychiatric illness, or suicidal ideation or behavior
- Pregnant, breastfeeding, or planning pregnancy during the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tortugas Neuroscience Clinical Trials Coordinator contact
About this study
Official title: An Open-Label Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Dose of a New Tablet Formulation of TRTL-729 in Healthy Adults
This study assesses the safety, tolerability, and pharmacokinetics (PK) of the tablet formulation of TRTL-729 in healthy adults.
- Conditions
- Healthy Volunteers
- Being tested
- TRTL-729
- Keywords
- TRTL-729
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRTL-729Drug
Participants will receive TRTL-729 tablets.
| Study group | Role | What they receive |
|---|---|---|
| TRTL-729 | Experimental | Participants will receive a single dose of TRTL-729 immediate-release tablet, administered orally. Receives: Drug: TRTL-729 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up to Day 10
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and Electrocardiograms (ECGs)
Measured: Up to Day 10
Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: Up to Day 10
Secondary outcomes (10)
Plasma Concentrations of TRTL-729
Measured: From pre-dose on Day 1 through Day 10
Maximum Observed Plasma Concentration (Cmax) of TRTL-729
Measured: From pre-dose on Day 1 through Day 10
Time to Maximum Plasma Concentration (Tmax) of TRTL-729
Measured: From pre-dose on Day 1 through Day 10
AUC From 0 to 24 Hours [AUC(0-24h)] of TRTL-729
Measured: From pre-dose on Day 1 through Day 10
Area Under the Plasma Concentration-Time Curve [AUC(0-t)] of TRTL-729
Measured: From pre-dose on Day 1 through Day 10
AUC From 0 to 72 Hours [AUC(0-72h)] of TRTL-729
Measured: From pre-dose on Day 1 through Day 10
AUC from Time 0 Extrapolated to Infinity (AUC(0-inf)) of TRTL-729
Measured: From pre-dose on Day 1 through Day 10
Apparent Terminal Elimination Half-Life (t1/2) of TRTL-729
Measured: From pre-dose on Day 1 through Day 10
Apparent Total Plasma Clearance After Oral Administration (CL/F) of TRTL-729
Measured: From pre-dose on Day 1 through Day 10
Apparent Volume of Distribution During Terminal Phase (Vz/F) of TRTL-729
Measured: From pre-dose on Day 1 through Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start28 Sep 2026
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tortugas Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07811063
- Sponsor's protocol ID
- 729-CLP-101
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2026
- Last updated
- 23 Oct 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of a Single Dose of a New Tablet Formulation of TRTL-729 in Healthy Adults
- ClinicalTrials.gov ID
- NCT07811063
- Acronym / sponsor ID
- 729-CLP-101
- Conditions
- Healthy Volunteers
- Keywords
- TRTL-729
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tortugas Neuroscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 9 Sep 2026 (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.
This study assesses the safety, tolerability, and pharmacokinetics (PK) of the tablet formulation of TRTL-729 in healthy adults.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRTL-729 | Experimental | Drug: TRTL-729Participants will receive a single dose of TRTL-729 immediate-release tablet, administered orally. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Generally healthy, ambulatory male or female adults aged 18 to 55 years, as determined by the investigator.
- Able and willing to provide written informed consent and comply with all study procedures and the visit schedule.
- Body Mass Index (BMI) 18.0 to 32.0 kilograms per meter square kg/m^2 and body weight greater than (>)50 kilograms (kg).
- Clinically acceptable medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead electrocardiogram (ECG), as determined by the investigator.
- QT interval Corrected using Fridericia's Formula (QTcF) lesser than or equal to (≤)450 milliseconds (msec) for males or ≤470 msec for females.
Key exclusion criteria (10 listed)
- Any clinically significant acute or chronic medical condition that, in the investigator's opinion, could affect participant safety or study assessments.
- History of seizures, epilepsy, significant head injury associated with loss of consciousness, family history of seizures or epilepsy, or other conditions or medications that increase seizure risk.
- Clinically significant cardiovascular, cerebrovascular, or peripheral vascular disease, clinically significant ECG abnormalities, torsade de pointes, or a family history of long QT syndrome or sudden cardiac death.
- Active infection or clinically significant recent illness before screening or dosing.
- Positive test for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C.
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 |
|---|---|---|
| TRTL-729Participants will receive TRTL-729 tablets. | Drug | TRTL-729 |
Primary outcome
Number of Participants With Treatment-Emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 10
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and Electrocardiograms (ECGs)
Time frame: Up to Day 10
Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 10
10 secondary outcomes
Plasma Concentrations of TRTL-729
Time frame: From pre-dose on Day 1 through Day 10
Maximum Observed Plasma Concentration (Cmax) of TRTL-729
Time frame: From pre-dose on Day 1 through Day 10
Time to Maximum Plasma Concentration (Tmax) of TRTL-729
Time frame: From pre-dose on Day 1 through Day 10
AUC From 0 to 24 Hours [AUC(0-24h)] of TRTL-729
Time frame: From pre-dose on Day 1 through Day 10
Area Under the Plasma Concentration-Time Curve [AUC(0-t)] of TRTL-729
Time frame: From pre-dose on Day 1 through Day 10
AUC From 0 to 72 Hours [AUC(0-72h)] of TRTL-729
Time frame: From pre-dose on Day 1 through Day 10
AUC from Time 0 Extrapolated to Infinity (AUC(0-inf)) of TRTL-729
Time frame: From pre-dose on Day 1 through Day 10
Apparent Terminal Elimination Half-Life (t1/2) of TRTL-729
Time frame: From pre-dose on Day 1 through Day 10
Apparent Total Plasma Clearance After Oral Administration (CL/F) of TRTL-729
Time frame: From pre-dose on Day 1 through Day 10
Apparent Volume of Distribution During Terminal Phase (Vz/F) of TRTL-729
Time frame: From pre-dose on Day 1 through Day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 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.
Tortugas Neuroscience Clinical Trials Coordinator contact
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 TRTL-729 in people with Healthy Volunteers, run by Tortugas Neuroscience, Inc. at 1 site in New Zealand.
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 8 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 23 Oct 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 New Zealand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tortugas Neuroscience Clinical Trials Coordinator (508-834-6470, clinicaltrials@tortugasneuro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Treatment-Emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up to Day 10). The study lists 3 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 23 Oct 2026.