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

Mylan

Status and phase: Completed; Phase 1

Conditions: Cardiac Repolarization in Healthy Subjects

Treatments: Drug: TD-4208 700 mcg; Drug: Moxifloxacin 400 mg; Drug: Placebo for TD-4208; Drug: TD-4208 175 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT02820311

0136

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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48 participants in 4 patient groups, including a placebo group

TD-4208 175 mcg

Experimental group

Description:

double-blind

Treatment:

Drug: TD-4208 175 mcg

TD-4208 700 mcg

Experimental group

Description:

double-blind

Treatment:

Drug: TD-4208 700 mcg

Placebo for TD-4208

Placebo Comparator group

Description:

double-blind

Treatment:

Drug: Placebo for TD-4208

Moxifloxacin 400 mg

Active Comparator group

Description:

open-label

Treatment:

Drug: Moxifloxacin 400 mg