TinnitusPhase 2NCT07777549
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
A Phase 2 study testing TRTL-913 in people with Tinnitus, run by Tortugas Neuroscience, Inc. at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Tinnitus
- What is being tested?
- TRTL-913
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 14 Oct 2026to Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A Inclusion Criteria:
- 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.
Show all 18Show fewer
- 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.
- Part B Inclusion Criteria:
- 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.
- Male participants must agree to use appropriate contraception and refrain from sperm donation for the required study period.
Who cannot join
- Part A Exclusion Criteria:
- 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.
Show all 23Show fewer
- 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.
- Part B Exclusion Criteria:
- 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.
- Clinically significant acute or chronic medical condition that, in the investigator's opinion, could affect participant safety or study assessments.
- Positive test for HIV, hepatitis B, or hepatitis C.
- 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.
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Tortugas Neuroscience Clinical Trials Coordinator contact
10 sites in 2 countries
Australia5 sites, 5 recruiting
- Not yet recruiting
Clinical Trial Site
Newcastle, New South Wales
- Not yet recruiting
Clinical Trial Site
Southport, Queensland
- Not yet recruiting
Clinical Trial Site
Sydney, New South Wales
- Not yet recruiting
Clinical Trial Site
Torquay, Victoria
- Not yet recruiting
Clinical Trial Site
Waitara, New South Wales
New Zealand5 sites, 5 recruiting
- Recruiting
Clinical Trial Site
Auckland
- Not yet recruiting
Clinical Trial Site
Christchurch
- Not yet recruiting
Clinical Trial Site
Nelson
- Not yet recruiting
Clinical Trial Site
Rotorua
- Not yet recruiting
Clinical Trial Site
Wellington
About this study
Official title: A Phase 2a, Randomized, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TRTL-913 in Healthy Adult Volunteers Under Fed Conditions (Part A), and an Open-Label Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Efficacy in Adults With Tinnitus (Part B)
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
- Being tested
- TRTL-913, Placebo
- Keywords
- TRTL-913, Tinnitus
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRTL-913Drug
Participants will receive TRTL-913 capsules QD.
PlaceboDrug
Participants will receive TRTL-913 matching placebo capsules QD.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: TRTL-913 |
| Part A: Placebo | Placebo comparator | Participants will receive TRTL-913 matching placebo administered QD on Day 1 through Day 7. Receives: 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. Receives: Drug: TRTL-913 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured: Up to Day 16
Part B: Number of Participants With TEAEs and SAEs
Measured: Up to Day 21
Part A: Number of Participants with Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and Electrocardiograms (ECGs)
Measured: Up to Day 16
Part B: Number of Participants with Clinically Significant Change From Baseline in Vital Signs, Clinical Laboratory Values, and ECGs
Measured: 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)
Measured: Up to Day 16
Part B: Number of Participants With Suicidal Ideation or Behavior as Assessed by the C-SSRS
Measured: Up to Day 21
Secondary outcomes (15)
Part A: Plasma Concentrations of TRTL-913
Measured: From predose on Day 1 through Day 8
Part A: Maximum Observed Plasma Concentration (Cmax) of TRTL-913
Measured: From predose on Day 1 through Day 8
Part A: Time to Maximum Plasma Concentration (Tmax) of TRTL-913
Measured: From predose on Day 1 through Day 8
Part A: Area Under the Plasma Concentration-Time Curve (AUC(0-t)) of TRTL-913
Measured: From predose on Day 1 through Day 8
Part A: AUC From 0 to 24 Hours (AUC(0-24h)) of TRTL-913
Measured: From predose on Day 1 through Day 8
Part A: AUC from time 0 extrapolated to infinity (AUC(0-inf)) of TRTL-913
Measured: From predose on Day 1 through Day 8
Part A: Apparent Terminal Elimination Half-Life (t1/2) of TRTL-913
Measured: From predose on Day 1 through Day 8
Part A: Apparent Total Plasma Clearance After Oral Administration (CL/F) of TRTL-913
Measured: From predose on Day 1 through Day 8
Part A: Apparent Volume of Distribution During Terminal Phase (Vz/F) of TRTL-913
Measured: From predose on Day 1 through Day 8
Part A: Accumulation Ratio for AUC (Rac AUC) of TRTL-913
Measured: From predose on Day 1 through Day 8
Part A: Accumulation Ratio for Cmax (Rac Cmax) of TRTL-913
Measured: From predose on Day 1 through Day 8
Part B: Change From Baseline in Tinnitus Functional Index (TFI) Total and Subscale Scores
Measured: From Baseline to Day 21
Part B: Change From Baseline in Tinnitus Handicap Inventory (THI) Score
Measured: From Baseline to Day 21
Part B: Change From Baseline in the Visual Analog Scale - Loudness (VAS-L) Score
Measured: From Baseline to Day 21
Part B: Change From Baseline in Visual Analog Scale - Annoyance (VAS-A) Score
Measured: From Baseline to Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start14 Oct 2026
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tortugas Neuroscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777549
- Sponsor's protocol ID
- 913-TNS-201
- Status last verified
- Nov 2026
- First submitted
- 17 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Randomized, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of TRTL-913 in Healthy Adult Volunteers Under Fed Conditions (Part A), and an Open-Label Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Efficacy in Adults With Tinnitus (Part B)
- ClinicalTrials.gov ID
- NCT07777549
- Acronym / sponsor ID
- 913-TNS-201
- Conditions
- Tinnitus
- Keywords
- TRTL-913, Tinnitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tortugas Neuroscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Oct 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 20 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: Multiple Ascending Doses of TRTL-913 | Experimental | Drug: TRTL-913Participants will receive TRTL-913 immediate-release capsules administered once daily (QD) on Day 1 through Day 7. |
| Part A: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive TRTL-913 matching placebo administered QD on Day 1 through Day 7. |
| Part B: TRTL-913 | Experimental | Drug: TRTL-913Participants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRTL-913Participants will receive TRTL-913 capsules QD. | Drug | Part A: Multiple Ascending Doses of TRTL-913, Part B: TRTL-913 |
| PlaceboParticipants will receive TRTL-913 matching placebo capsules QD. | Drug | Part A: Placebo |
Primary outcome
Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: Up to Day 16
Part B: Number of Participants With TEAEs and SAEs
Time frame: Up to Day 21
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
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
Part A: Number of Participants With Suicidal Ideation or Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Day 16
Part B: Number of Participants With Suicidal Ideation or Behavior as Assessed by the C-SSRS
Time frame: Up to Day 21
15 secondary outcomes
Part A: Plasma Concentrations of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: Maximum Observed Plasma Concentration (Cmax) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: Time to Maximum Plasma Concentration (Tmax) of TRTL-913
Time frame: From predose on Day 1 through Day 8
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
Part A: AUC From 0 to 24 Hours (AUC(0-24h)) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: AUC from time 0 extrapolated to infinity (AUC(0-inf)) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: Apparent Terminal Elimination Half-Life (t1/2) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: Apparent Total Plasma Clearance After Oral Administration (CL/F) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: Apparent Volume of Distribution During Terminal Phase (Vz/F) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: Accumulation Ratio for AUC (Rac AUC) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part A: Accumulation Ratio for Cmax (Rac Cmax) of TRTL-913
Time frame: From predose on Day 1 through Day 8
Part B: Change From Baseline in Tinnitus Functional Index (TFI) Total and Subscale Scores
Time frame: From Baseline to Day 21
Part B: Change From Baseline in Tinnitus Handicap Inventory (THI) Score
Time frame: From Baseline to Day 21
Part B: Change From Baseline in the Visual Analog Scale - Loudness (VAS-L) Score
Time frame: From Baseline to Day 21
Part B: Change From Baseline in Visual Analog Scale - Annoyance (VAS-A) Score
Time frame: From Baseline to Day 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Tinnitus
Not yet recruitingPhase 1/2
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
Tinnitus, Chronic Subjective Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Not yet recruiting
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
Sensorineural Hearing Loss, Tinnitus
Enrolling by invitationObservational study
Comparing an AI-driven Hearing Test With the Standard Hearing Test in Adults With Hearing Loss and Tinnitus
Sensorineural Hearing Loss, Tinnitus
Recruiting
Deep Repetitive Transcranial Magnetic Stimulation in the Treatment of Tinnitus
Tinnitus, Tinnitus, Bilateral
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tortugas Neuroscience Clinical Trials Coordinator contact
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TRTL-913 in people with Tinnitus, run by Tortugas Neuroscience, Inc. at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Australia, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tortugas Neuroscience Clinical Trials Coordinator (508-834-6470, clinicaltrials@tortugasneuro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Up to Day 16). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026; AzTrials last refreshed its copy on 8 Nov 2026.