CompletedNCT02820311Updated Feb 24, 2022

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

A Phase 1 interventional study of TD-4208 175 mcg and TD-4208 700 mcg in Cardiac Repolarization in Healthy Subjects, sponsored by Mylan Inc.. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-24.

Sponsored by Mylan Inc. · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 48
Allocation: Randomized
Ages: 18 Years to 55 Years
Sex: All

Study 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.

Conditions studied

Cardiac Repolarization in Healthy Subjects

Keywords

Thorough QT (TQT)
cardiac safety

In context

Lead sponsor

Mylan Inc. is the lead sponsor of 43 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 55 Years
Sexes eligible: All
Accepts 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

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

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 48 participants (actual)

Study arms

Experimental
TD-4208 175 mcg
double-blind
Drug: TD-4208 175 mcg
Experimental
TD-4208 700 mcg
double-blind
Drug: TD-4208 700 mcg
Placebo comparator
Placebo for TD-4208
double-blind
Drug: Placebo for TD-4208
Active comparator
Moxifloxacin 400 mg
open-label
Drug: Moxifloxacin 400 mg

Interventions

DrugTD-4208 175 mcg
via nebulizer
Also known as: revefenacin
DrugTD-4208 700 mcg
via nebulizer
Also known as: revefenacin
DrugPlacebo for TD-4208
via nebulizer
DrugMoxifloxacin 400 mg
oral
Also known as: Avelox

What researchers measure

Primary outcomes

Change-from-baseline in corrected QT
Time frame: Predose to 24 hours postdose

Secondary outcomes

Maximum Plasma Concentration Cmax
Time frame: Predose to 24 hours postdose
Adverse Events
Time frame: Predose to 24 hours postdose

Study locations

1 site

Celerion
Tempe, Arizona 85283, United States

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02820311
Lead sponsor: Mylan Inc.
Collaborators: Theravance Biopharma
Responsible party: Sponsor
First posted: Jun 30, 2016
Start date: May 2016
Primary completion: Jul 2016
Completion: Jul 2016
Last update: Feb 24, 2022

Study contacts

Medical Monitor

study director · Theravance Biopharma

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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