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NCT Number: NCT07811063

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

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trial Site

Auckland, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

TRTL-729

Drug

Participants will receive TRTL-729 tablets.

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

Sponsors and collaborators

Lead sponsor

Tortugas Neuroscience, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 9, 2026
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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