A single-dose tablet of TRTL-729 tested in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This early-phase study administers a one-time tablet dose of TRTL-729 to healthy volunteers. The goal is to characterize safety, tolerability, and pharmacokinetics in adults aged 18 to 55. Participants will undergo medical screening, receive the tablet under supervision, and be monitored for adverse effects and blood-level measurements. The study includes strict inclusion/exclusion criteria and confinement during the dosing period. Data will inform dosing and safety for future trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• Clinical Trial Site
  Auckland, New Zealand Recruiting

Study contacts

• Study coordinator: Tortugas Neuroscience Clinical Trials Coordinator
• Email: clinicaltrials@tortugasneuro.com
• Phone: 508-834-6470

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.