Thorough QT (TQT) Study of TD-4208 in Healthy Subjects

Study Overview
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Brief Summary
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The purpose of this study is to evaluate if TD-4208, an investigational drug being developed to treat people with chronic obstructive pulmonary disease (COPD), has any effect on the electrical activity of the heart.

Official Title
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A Phase 1, Randomized, Double-Blind, Placebo- and Positive-Controlled, 4-Period Crossover Thorough QT Study to Evaluate the Effect of a Single Dose of TD-4208 on Cardiac Repolarization in Healthy Subjects

Conditions
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Cardiac Repolarization in Healthy Subjects

Intervention / Treatment
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* Drug: TD-4208 175 mcg
* Drug: TD-4208 700 mcg
* Drug: Placebo for TD-4208
* Drug: Moxifloxacin 400 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has a body mass index (BMI) of 19 to 32 kg/m2, inclusive, and weight of at least 55 kg. Subject is able to communicate well with the investigator and to comply with the study procedures, requirements, and restrictions. Exclusion Criteria: Subject has a prior history of myocardial infarction, acute coronary syndrome, cerebrovascular accident, transient ischemic attack, ventricular tachycardia, atrial fibrillation, personal or known family history of congenital long QT syndrome or known family history of sudden death with unknown cause, a pacemaker or implantable cardioverter defibrillator, cardiac or cerebral stent placement or angioplasty, or clinically significant valvular heart disease. Subject has evidence or history of clinically significant allergic (except for untreated, asymptomatic, seasonal allergies at time of dosing), hematologic, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TD-4208 175 mcg<br>double-blind | Drug: TD-4208 175 mcg<br>* via nebulizer<br>* Other names: revefenacin;|
| Experimental: TD-4208 700 mcg<br>double-blind | Drug: TD-4208 700 mcg<br>* via nebulizer<br>* Other names: revefenacin;|
| Placebo Comparator: Placebo for TD-4208<br>double-blind | Drug: Placebo for TD-4208<br>* via nebulizer<br>|
| Active Comparator: Moxifloxacin 400 mg<br>open-label | Drug: Moxifloxacin 400 mg<br>* oral<br>* Other names: Avelox;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change-from-baseline in corrected QT |  | Predose to 24 hours postdose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration Cmax |  | Predose to 24 hours postdose | 
| Adverse Events |  | Predose to 24 hours postdose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thorough QT (TQT), cardiac safety