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

Sponsor

Mylan Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02820311

Collaborator

Theravance Biopharma (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Repolarization in Healthy Subjects	Drug: TD-4208 175 mcg Drug: TD-4208 700 mcg Drug: Placebo for TD-4208 Drug: Moxifloxacin 400 mg	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official 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

Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Jul 1, 2016

Actual Study Completion Date :

Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TD-4208 175 mcg double-blind	Drug: TD-4208 175 mcg via nebulizer Other Names: revefenacin
Experimental: TD-4208 700 mcg double-blind	Drug: TD-4208 700 mcg via nebulizer Other Names: revefenacin
Placebo Comparator: Placebo for TD-4208 double-blind	Drug: Placebo for TD-4208 via nebulizer
Active Comparator: Moxifloxacin 400 mg open-label	Drug: Moxifloxacin 400 mg oral Other Names: Avelox

Outcome Measures

Primary Outcome Measures

Change-from-baseline in corrected QT [Predose to 24 hours postdose]

Secondary Outcome Measures

Maximum Plasma Concentration Cmax [Predose to 24 hours postdose]
Adverse Events [Predose to 24 hours postdose]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion	Tempe	Arizona	United States	85283

Sponsors and Collaborators

Mylan Inc.
Theravance Biopharma

Investigators

Study Director: Medical Monitor, Theravance Biopharma

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mylan Inc.

ClinicalTrials.gov Identifier:

NCT02820311

Other Study ID Numbers:

0136

First Posted:

Jun 30, 2016

Last Update Posted:

Feb 24, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Mylan Inc.

Thorough QT (TQT)

cardiac safety

Additional relevant MeSH terms:

Moxifloxacin

Study Results

No Results Posted as of Feb 24, 2022