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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2016-07-31

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.

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Detailed Description

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Conditions

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Cardiac Repolarization in Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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TD-4208 175 mcg

double-blind

Group Type EXPERIMENTAL

TD-4208 175 mcg

Intervention Type DRUG

via nebulizer

TD-4208 700 mcg

double-blind

Group Type EXPERIMENTAL

TD-4208 700 mcg

Intervention Type DRUG

via nebulizer

Placebo for TD-4208

double-blind

Group Type PLACEBO_COMPARATOR

Placebo for TD-4208

Intervention Type DRUG

via nebulizer

Moxifloxacin 400 mg

open-label

Group Type ACTIVE_COMPARATOR

Moxifloxacin 400 mg

Intervention Type DRUG

oral

Interventions

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TD-4208 175 mcg

via nebulizer

Intervention Type DRUG

TD-4208 700 mcg

via nebulizer

Intervention Type DRUG

Placebo for TD-4208

via nebulizer

Intervention Type DRUG

Moxifloxacin 400 mg

oral

Intervention Type DRUG

Other Intervention Names

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revefenacin revefenacin Avelox

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes