Health TrialsbyHealthPanel

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

ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorTortugas Neuroscience, Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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/m² 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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • TRTL-729

    Drug

    Participants will receive TRTL-729 tablets.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: TRTL-729Experimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tortugas Neuroscience, Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: