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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Clinical Trial Site
Auckland, New Zealand
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
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
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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