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

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiac Repolarization in Healthy Subjects
• Intervention / Treatment: Drug: TD-4208 175 mcg; Drug: TD-4208 700 mcg; Drug: Placebo for TD-4208; Drug: Moxifloxacin 400 mg

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mylan Inc.
• Collaborators: Theravance Biopharma

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: June 28, 2016
• First Posted (Estimate): June 30, 2016

Study Record Updates

• Last Update Posted (Actual): February 24, 2022
• Last Update Submitted That Met QC Criteria: February 22, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Thorough QT (TQT); cardiac safety
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin
• Other Study ID Numbers: 0136

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO