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

Phase 1

Completed

• Conditions: Cardiac Repolarization in Healthy Subjects
• Interventions: Drug: TD-4208 175 mcg; Drug: TD-4208 700 mcg; Drug: Placebo for TD-4208; Drug: Moxifloxacin 400 mg

• Registration Number: NCT02820311
• Lead Sponsor: Mylan Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-06-30
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-22
• Last Update Posted: 2022-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
TD-4208 175 mcg	TD-4208 175 mcg	double-blind
TD-4208 700 mcg	TD-4208 700 mcg	double-blind
Placebo for TD-4208	Placebo for TD-4208	double-blind
Moxifloxacin 400 mg	Moxifloxacin 400 mg	open-label

Primary Outcome Measures

Name	Time	Method
Change-from-baseline in corrected QT	Predose to 24 hours postdose

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Predose to 24 hours postdose
Maximum Plasma Concentration Cmax	Predose to 24 hours postdose

Trial Locations

Locations (1)

Celerion; 🇺🇸 Tempe, Arizona, United States