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

NCT07777549 | Not Yet Recruiting Phase 2

• 1 other identifier: 913-TNS-201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tinnitus

Keywords

TRTL-913; Tinnitus

Outcome Measures

Primary Outcomes (6)

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

  Up to Day 16

• Part B: Number of Participants With TEAEs and SAEs

  Up to Day 21

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

  Up to Day 16

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

  Up to Day 21

• Part A: Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)

  Up to Day 16

• Part B: Number of Participants With Suicidal Ideation or Behavior as Assessed by the C-SSRS

  Up to Day 21

Secondary Outcomes (15)

• Part A: Plasma Concentrations of TRTL-913

  From predose on Day 1 through Day 8

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

  From predose on Day 1 through Day 8

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

  From predose on Day 1 through Day 8

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

  From predose on Day 1 through Day 8

• Part A: AUC From 0 to 24 Hours (AUC(0-24h)) of TRTL-913

  From predose on Day 1 through Day 8

Study Arms (3)

Part A: Multiple Ascending Doses of TRTL-913

EXPERIMENTAL

Participants will receive TRTL-913 immediate-release capsules administered once daily (QD) on Day 1 through Day 7.

Drug: TRTL-913

Part A: Placebo

PLACEBO COMPARATOR

Participants will receive TRTL-913 matching placebo administered QD on Day 1 through Day 7.

Drug: Placebo

Part B: TRTL-913

EXPERIMENTAL

Participants will self-administer TRTL-913 immediate-release capsules QD on Day 1 through Day 14. Additional doses will be based on the results from Part A.

Drug: TRTL-913

Interventions

TRTL-913 DRUG

Participants will receive TRTL-913 capsules QD.

Part A: Multiple Ascending Doses of TRTL-913; Part B: TRTL-913

Placebo DRUG

Participants will receive TRTL-913 matching placebo capsules QD.

Part A: Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/m\^2) 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.
• QT interval corrected using the Fridericia method (QTcF) of less than or equal to (≤) 450 millisecond (msec) for males or ≤470 msec for females.
• Nonsmokers or light smokers (\<10 cigarettes/week or equivalent vaping) for at least 3 months before dosing and willing to abstain during confinement.
• Women of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception throughout the required study period.
• Male participants must agree to use appropriate contraception and refrain from sperm donation for the required study period.
• Male or female adults aged 18 to 64 years.
• Able and willing to provide written informed consent and comply with study procedures.
• Diagnosis of subjective, stable, chronic, non-pulsatile tinnitus.
• Generally healthy aside from tinnitus, with no clinically significant abnormalities on medical history, physical or neurologic examination, vital signs, laboratory tests, or ECG that would interfere with study participation.
• BMI 18.0 to 35.0 kg/m\^2 and body weight \>50 kg.
• Willing to discontinue prohibited medications and substances before study treatment and throughout study participation.
• Women of childbearing potential must have a negative pregnancy test and agree to use highly effective contraception throughout the required study period.

You may not qualify if:

• 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.
• Active infection or clinically significant recent illness before screening or dosing.
• Positive test for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
• Clinically significant hepatic or renal impairment or clinically significant laboratory abnormalities.
• History of malignancy within the past 10 years (except adequately treated nonmelanoma skin cancer or cervical carcinoma in situ).
• Current or recent substance or alcohol use disorder or positive drug or alcohol screening.
• Current or history of clinically significant psychiatric illness or suicidal ideation or behavior that would increase study risk.
• Pregnant, breastfeeding, or planning pregnancy during the study.
• Current use of, or plans to initiate, pharmacologic or non-pharmacologic treatment for tinnitus during the study.
• Regular night-shift work that could interfere with study assessments.
• Use of prohibited medications, including moderate or strong CYP450 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.

Sponsors & Collaborators

• Tortugas Neuroscience, Inc.: lead

Study Sites (1)

Clinical Trial Site

Auckland, New Zealand

Location

MeSH Terms

Conditions

Tinnitus

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Part A is blinded, Part B is open label.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 20, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)