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

NCT07777549 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-20

No results posted yet for this study

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

Interventions

DRUG

TRTL-913

Participants will receive TRTL-913 capsules QD.

DRUG

Placebo

Participants will receive TRTL-913 matching placebo capsules QD.

Sponsors & Collaborators

  • Tortugas Neuroscience, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • New Zealand

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07777549 on ClinicalTrials.gov