Tinnitus
Conditions
Keywords
TRTL-913, Tinnitus
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.
Interventions
DRUGTRTL-913
Participants will receive TRTL-913 capsules QD.
DRUGPlacebo
Participants will receive TRTL-913 matching placebo capsules QD.
Sponsors
Tortugas Neuroscience, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Part A is blinded, Part B is open label.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
Part A Inclusion Criteria: 1. 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. 2. Able and willing to provide written informed consent and comply with all study procedures. 3. Body mass index (BMI) 18.0 to 35.0 kilograms per square meter (kg/m\^2) and body weight greater than (\>) 50 kilogram (kg). 4. Clinically acceptable medical history, physical examination, vital signs, clinical laboratory tests, and 12-lead ECG, as determined by the investigator. 5. QT interval corrected using the Fridericia method (QTcF) of less than or equal to (≤) 450 millisecond (msec) for males or ≤470 msec for females. 6. Nonsmokers or light smokers (\<10 cigarettes/week or equivalent vaping) for at least 3 months before dosing and willing to abstain during confinement. 7. Women 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. Part B Inclusion Criteria: 1. Male or female adults aged 18 to 64 years. 2. Able and willing to provide written informed consent and comply with study procedures. 3. Diagnosis of subjective, stable, chronic, non-pulsatile tinnitus. 4. 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. 5. BMI 18.0 to 35.0 kg/m\^2 and body weight \>50 kg. 6. Willing to discontinue prohibited medications and substances before study treatment and throughout study participation. 7. Women 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
Part A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Part A: AUC from time 0 extrapolated to infinity (AUC(0-inf)) of TRTL-913 | From predose on Day 1 through Day 8 |
| Part A: Apparent Terminal Elimination Half-Life (t1/2) of TRTL-913 | From predose on Day 1 through Day 8 |
| Part A: Apparent Total Plasma Clearance After Oral Administration (CL/F) of TRTL-913 | From predose on Day 1 through Day 8 |
| Part A: Apparent Volume of Distribution During Terminal Phase (Vz/F) of TRTL-913 | From predose on Day 1 through Day 8 |
| Part A: Accumulation Ratio for AUC (Rac AUC) of TRTL-913 | From predose on Day 1 through Day 8 |
| Part A: Accumulation Ratio for Cmax (Rac Cmax) of TRTL-913 | From predose on Day 1 through Day 8 |
| Part B: Change From Baseline in Tinnitus Functional Index (TFI) Total and Subscale Scores | From Baseline to Day 21 |
| Part B: Change From Baseline in Tinnitus Handicap Inventory (THI) Score | From Baseline to Day 21 |
| Part B: Change From Baseline in the Visual Analog Scale - Loudness (VAS-L) Score | From Baseline to Day 21 |
| Part B: Change From Baseline in Visual Analog Scale - Annoyance (VAS-A) Score | From Baseline to Day 21 |
Countries
New Zealand
Outcome results
None listed