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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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02820311
Enrollment
48
Registered
2016-06-30
Start date
2016-05-31
Completion date
2016-07-31
Last updated
2022-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Repolarization in Healthy Subjects

Keywords

Thorough QT (TQT), cardiac safety

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.

Interventions

DRUGTD-4208 175 mcg

via nebulizer

DRUGTD-4208 700 mcg

via nebulizer

DRUGPlacebo for TD-4208

via nebulizer

DRUGMoxifloxacin 400 mg

oral

Sponsors

Theravance Biopharma
CollaboratorINDUSTRY
Mylan Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
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.

Design outcomes

Primary

MeasureTime frame
Change-from-baseline in corrected QTPredose to 24 hours postdose

Secondary

MeasureTime frame
Maximum Plasma Concentration CmaxPredose to 24 hours postdose
Adverse EventsPredose to 24 hours postdose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026