Health TrialsbyHealthPanel

A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)

ConditionTinnitus
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorTortugas Neuroscience, Inc.

About this trial

This study will consist of two parts. Double blind Part A will assess the safety, tolerability, and pharmacokinetics of 7 days of dosing in healthy adults, while open label Part B will evaluate the safety, tolerability, and efficacy of a 2-week treatment course in adults with tinnitus.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy male or female adults aged 18 to 64 years (or 65 to 80 years for an elderly cohort, if enrolled), as determined by the investigator.

Able and willing to provide written informed consent and comply with all study procedures.

Body mass index (BMI) 18.0 to 35.0 kilograms per square meter (kg/m²) and body weight greater than (>) 50 kilogram (kg).

Clinically acceptable medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead 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.

Use of prohibited medications, including moderate or strong cytochrome (CY)P450 inhibitors or inducers, or other prohibited foods or supplements before dosing.

History of seizures, epilepsy, significant head injury associated with loss of consciousness, or other conditions or medications that increase seizure risk.

Clinically significant cardiovascular disease, clinically significant ECG abnormalities, long QT syndrome, torsade de pointes, or a family history of long QT syndrome or sudden cardiac death.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TRTL-913

    Drug

    Participants will receive TRTL-913 capsules QD.

  • Placebo

    Drug

    Participants will receive TRTL-913 matching placebo capsules QD.

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Part A: Multiple Ascending Doses of TRTL-913Experimental treatment 1 intervention
Group B: Part A: PlaceboPlacebo comparator 1 intervention
Group C: Part B: TRTL-913Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame
Up to Day 16
2

Part B: Number of Participants With TEAEs and SAEs

Time frame
Up to Day 21
3

Part A: Number of Participants with Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and Electrocardiograms (ECGs)

Time frame
Up to Day 16
4

Part B: Number of Participants with Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and ECGs

Time frame
Up to Day 21

Secondary outcomes

1

Part A: Plasma Concentrations of TRTL-913

Time frame
From predose on Day 1 through Day 8
2

Part A: Maximum Observed Plasma Concentration (Cmax) of TRTL-913

Time frame
From predose on Day 1 through Day 8
3

Part A: Time to Maximum Plasma Concentration (Tmax) of TRTL-913

Time frame
From predose on Day 1 through Day 8
4

Part A: Area Under the Plasma Concentration-Time Curve (AUC(0-t)) of TRTL-913

Time frame
From predose on Day 1 through Day 8

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: