Healthy Volunteers
Conditions
Keywords
TRTL-729
Brief summary
This study assesses the safety, tolerability, and pharmacokinetics (PK) of the tablet formulation of TRTL-729 in healthy adults.
Interventions
DRUGTRTL-729
Participants will receive TRTL-729 tablets.
Sponsors
Tortugas Neuroscience, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Time to Maximum Plasma Concentration (Tmax) 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 |
| 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 |
| Apparent Total Plasma Clearance After Oral Administration (CL/F) 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 |
Countries
New Zealand
Outcome results
None listed