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
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2016
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 23, 2016
CompletedFirst Posted
Study publicly available on registry
June 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedFebruary 24, 2022
February 1, 2022
2 months
June 23, 2016
February 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change-from-baseline in corrected QT
Predose to 24 hours postdose
Secondary Outcomes (2)
Maximum Plasma Concentration Cmax
Predose to 24 hours postdose
Adverse Events
Predose to 24 hours postdose
Study Arms (4)
TD-4208 175 mcg
EXPERIMENTALdouble-blind
TD-4208 700 mcg
EXPERIMENTALdouble-blind
Placebo for TD-4208
PLACEBO COMPARATORdouble-blind
Moxifloxacin 400 mg
ACTIVE COMPARATORopen-label
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mylan Inc.lead
- Theravance Biopharmacollaborator
Study Sites (1)
Celerion
Tempe, Arizona, 85283, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Theravance Biopharma
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2016
First Posted
June 30, 2016
Study Start
May 1, 2016
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
February 24, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share