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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: TRTL-729

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • Clinical Trial Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 informed consent and comply with all study procedures and the visit schedule.
3. Body Mass Index (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 electrocardiogram (ECG), as determined by the investigator.
5. QT interval 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 childbearing potential, must have a negative pregnancy test and agree to use highly effective contraception 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:

1. Any clinically significant 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 ECG abnormalities, torsade de pointes, or a family history of long QT syndrome or sudden cardiac death.
4. Active infection or clinically significant recent illness before screening or dosing.
5. Positive test for Human Immunodeficiency Virus (HIV), hepatitis B, or hepatitis C.
6. Clinically significant hepatic or renal impairment or clinically significant laboratory abnormalities.
7. History of malignancy 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TRTL-729; Participants will receive a single dose of TRTL-729 immediate-release tablet, administered orally.	Drug: TRTL-729; Participants will receive TRTL-729 tablets.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Treatment-Emergent Adverse events (TEAEs) and Serious Adverse Events (SAEs)	Up to Day 10
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and Electrocardiograms (ECGs)	Up to Day 10
Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)	Up to Day 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Plasma Concentrations of TRTL-729	From pre-dose on Day 1 through Day 10
Maximum Observed Plasma Concentration (Cmax) of TRTL-729	From pre-dose on Day 1 through Day 10
Time to Maximum Plasma Concentration (Tmax) of TRTL-729	From pre-dose on Day 1 through Day 10
AUC From 0 to 24 Hours [AUC(0-24h)] of TRTL-729	From pre-dose on Day 1 through Day 10
Area Under the Plasma Concentration-Time Curve [AUC(0-t)] of TRTL-729	From pre-dose on Day 1 through Day 10
AUC From 0 to 72 Hours [AUC(0-72h)] of TRTL-729	From pre-dose on Day 1 through Day 10
AUC from Time 0 Extrapolated to Infinity (AUC(0-inf)) of TRTL-729	From pre-dose on Day 1 through Day 10
Apparent Terminal Elimination Half-Life (t1/2) of TRTL-729	From pre-dose on Day 1 through Day 10
Apparent Total Plasma Clearance After Oral Administration (CL/F) of TRTL-729	From pre-dose on Day 1 through Day 10
Apparent Volume of Distribution During Terminal Phase (Vz/F) of TRTL-729	From pre-dose on Day 1 through Day 10

Collaborators and Investigators

• Sponsor: Tortugas Neuroscience, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: September 2, 2026
• First Submitted That Met QC Criteria: September 2, 2026
• First Posted (Actual): September 9, 2026

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: TRTL-729
• Other Study ID Numbers: 729-CLP-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No