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

Cardiac Repolarization in Healthy Subjects Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820311
• Other study ID #: 0136
• Status: Completed
• Phase: Phase 1
• Start date: May 2016
• Est. completion date: July 2016

Study information

• Verified date: February 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiac Repolarization in Healthy Subjects

Intervention

Drug:
• TD-4208 175 mcg
via nebulizer
• TD-4208 700 mcg
via nebulizer
• Placebo for TD-4208
via nebulizer
• Moxifloxacin 400 mg
oral

Locations

Country	Name	City	State
United States	Celerion	Tempe	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mylan Inc.	Theravance Biopharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change-from-baseline in corrected QT		Predose to 24 hours postdose
Secondary	Maximum Plasma Concentration Cmax		Predose to 24 hours postdose
Secondary	Adverse Events		Predose to 24 hours postdose