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Completed

NCT Number: NCT02820311

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

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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Key information

Conditions

Cardiac Repolarization in Healthy Subjects

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TD-4208 175 mcg

Drug

via nebulizer

Other names: revefenacin

TD-4208 700 mcg

Drug

via nebulizer

Other names: revefenacin

Placebo for TD-4208

Drug

via nebulizer

Moxifloxacin 400 mg

Drug

oral

Other names: Avelox

Primary outcomes

  1. Change-from-baseline in corrected QT

    Time frame: Predose to 24 hours postdose

Secondary outcomes

  1. Maximum Plasma Concentration Cmax

    Time frame: Predose to 24 hours postdose

  2. Adverse Events

    Time frame: Predose to 24 hours postdose

Sponsors and collaborators

Lead sponsor

Mylan Inc.

Industry

Collaborators

  • Theravance Biopharma

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jun 30, 2016
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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