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

NCT02820311 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2022-02-24

No results posted yet for this 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

  • Cardiac Repolarization in Healthy Subjects

Interventions

DRUG

TD-4208 175 mcg

via nebulizer

DRUG

TD-4208 700 mcg

via nebulizer

DRUG

Placebo for TD-4208

via nebulizer

DRUG

Moxifloxacin 400 mg

oral

Sponsors & Collaborators

  • Theravance Biopharma

    collaborator INDUSTRY

  • Mylan Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Theravance Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2016-07-31
Completion
2016-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02820311 on ClinicalTrials.gov