ClinicalTrials.gg
RecruitingNCT07811063Updated Oct 23, 2026

A Study to Test a Single Dose of a New Tablet Formulation of TRTL-729

A Phase 1 interventional study of TRTL-729 in Healthy Volunteers, sponsored by Tortugas Neuroscience, Inc.. Recruiting at 1 site in New Zealand. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Tortugas Neuroscience, Inc. · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Oct 23, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This study assesses the safety, tolerability, and pharmacokinetics (PK) of the tablet formulation of TRTL-729 in healthy adults.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • TRTL-729
03

In context

Lead sponsor

Tortugas Neuroscience, Inc. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Generally healthy, ambulatory male or female adults aged 18 to 55 years, as determined by the investigator.
  2. Able and willing to provide written and comply with all study procedures and the visit schedule.
  3. (BMI) 18.0 to 32.0 kilograms per meter square kg/m\^2 and body weight greater than (>)50 kilograms (kg).
  4. Clinically acceptable medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead (ECG), as determined by the investigator.
  5. Corrected using Fridericia's Formula (QTcF) lesser than or equal to (≤)450 milliseconds (msec) for males or ≤470 msec for females.
  6. 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.
  7. Females must be of nonchildbearing potential or, if of , must have a negative pregnancy test and agree to use highly effective throughout the required study period.
  8. Male participants must agree to use appropriate contraception and refrain from sperm donation for the required study period.

Exclusion criteria

Exclusion Criteria:

  1. Any acute or chronic medical condition that, in the investigator's opinion, could affect participant safety or study assessments.
  2. 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.
  3. Clinically significant cardiovascular, cerebrovascular, or peripheral vascular disease, clinically significant abnormalities, torsade de pointes, or a family history of long syndrome or sudden cardiac death.
  4. Active infection or clinically significant recent illness before screening or dosing.
  5. Positive test for (HIV), , or .
  6. Clinically significant hepatic or renal impairment or clinically significant laboratory abnormalities.
  7. History of within the past 10 years (except adequately treated nonmetastatic basal cell or squamous cell skin cancer or cervical carcinoma in situ).
  8. Current or recent substance or alcohol use disorder, or positive drug or alcohol screening.
  9. Current or history of clinically significant psychiatric illness, or suicidal ideation or behavior
  10. Pregnant, breastfeeding, or planning pregnancy during the study.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

QT and QTc

On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.

The study may name a correction formula and a limit in milliseconds, often around 450–480.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    TRTL-729

    Participants will receive a single dose of TRTL-729 immediate-release tablet, administered orally.

    Drug: TRTL-729

Interventions

  • DrugTRTL-729

    Participants will receive TRTL-729 tablets.

06

What researchers measure

Primary outcomes

  1. Number of Participants With Treatment-Emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Up to Day 10

  2. Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and Electrocardiograms (ECGs)

    Time frame: Up to Day 10

  3. 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

Secondary outcomes

  1. Plasma Concentrations of TRTL-729

    Time frame: From pre-dose on Day 1 through Day 10

  2. Maximum Observed Plasma Concentration (Cmax) of TRTL-729

    Time frame: From pre-dose on Day 1 through Day 10

  3. Time to Maximum Plasma Concentration (Tmax) of TRTL-729

    Time frame: From pre-dose on Day 1 through Day 10

  4. AUC From 0 to 24 Hours [AUC(0-24h)] of TRTL-729

    Time frame: From pre-dose on Day 1 through Day 10

  5. Area Under the Plasma Concentration-Time Curve [AUC(0-t)] of TRTL-729

    Time frame: From pre-dose on Day 1 through Day 10

  6. AUC From 0 to 72 Hours [AUC(0-72h)] of TRTL-729

    Time frame: From pre-dose on Day 1 through Day 10

  7. AUC from Time 0 Extrapolated to Infinity (AUC(0-inf)) of TRTL-729

    Time frame: From pre-dose on Day 1 through Day 10

  8. Apparent Terminal Elimination Half-Life (t1/2) of TRTL-729

    Time frame: From pre-dose on Day 1 through Day 10

  9. Apparent Total Plasma Clearance After Oral Administration (CL/F) of TRTL-729

    Time frame: From pre-dose on Day 1 through Day 10

  10. Apparent Volume of Distribution During Terminal Phase (Vz/F) of TRTL-729

    Time frame: From pre-dose on Day 1 through Day 10

07

Study locations

1 of 1 sites recruiting
  • Clinical Trial Site
    Auckland, New Zealand
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2026 (actual). Primary completion is estimated for Jan 2027, 4 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2026
First posted
Sep 9, 2026
StartActual
Sep 28, 2026
Primary completionEst.
Jan 2027
CompletionEst.
Jan 2027
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Oct 23, 2026
Sites
Clinical Trial Site is now Recruiting
Oct 23, 2026
Contact
Study contact now listed: added c•••@tortugasneuro.com · •••6470. See the current contact
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    Not yet recruiting→Recruiting
    Clinical Trial Site is now Recruiting
    Contact Study contact now listed: added c•••@tortugasneuro.com · •••6470. See the current contact
    + 2 other changes: verification date and date precision

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07811063
Lead sponsor
Tortugas Neuroscience, Inc.
Responsible party
Sponsor
First posted
Sep 9, 2026
Start date
Sep 28, 2026
Primary completion
Jan 2027 (estimated)
Completion
Jan 2027 (estimated)
Last update
Oct 23, 2026

Study contacts

Tortugas Neuroscience Clinical Trials Coordinator
Contact
clinicaltrials@tortugasneuro.com
508-834-6470

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion