7 Days of TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease

February 22, 2022 updated by: Mylan Inc.

A Phase 2 Study of the Pharmacodynamics, Safety and Tolerability, and Pharmacokinetics of Multiple Doses of TD-4208 for 7 Days in Subjects Diagnosed With Chronic Obstructive Pulmonary Disease

This study will characterize the dose response of TD-4208 after 7 days of dosing in subjects with Chronic Obstructive Pulmonary Disease (COPD).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is a male or female between the ages of 40 and 75 years (inclusive, at randomization).

  2. Subject:

    • Has an FEV1/FVC (forced expiratory volume in 1 second/forced vital capacity) <0.7 at screening; and
    • Has a post-bronchodilator FEV1 at screening of between 30% and 80% (inclusive) of the predicted normal value.
  3. Subject demonstrates at screening at least a 120 mL increase in FEV1 within 1 hour of receiving 500 µg of ipratropium bromide from a PARI LC Sprint® nebulizer.
  4. Females of non-childbearing potential. All male subjects must agree to use a highly effective method of birth control with partners of childbearing potential during the study and for 1 month after completion of study dosing.
  5. Subject (or care giver) is able to properly prepare and administer study medication.
  6. Subject is willing and able to give written informed consent to participate.

Exclusion Criteria:

  1. Subject has had a COPD exacerbation or lung infection within 6 weeks before randomization.
  2. Subject has had an initiation of treatment, or a change in dose, of an inhaled or oral corticosteroid, or long-acting beta2 agonist (LABA), or long-acting muscarinic antagonist (LAMA) within 4 weeks before the qualifying ipratropium bromide response test.
  3. Subject is taking daily maintenance inhaled/systemic corticosteroids (>1000 μg of fluticasone propionate equivalent or ≥10 mg prednisone).
  4. Subject has an uncontrolled hematologic, immunologic, renal, neurologic, hepatic, endocrine, or other disease or condition based on information gathered from the medical history, physical examination, or laboratory findings that might place the subject at undue risk or potentially compromise the results or interpretation of the study.
  5. Subject has a history of significant cerebrovascular disease, coronary artery disease, or cardiac arrhythmias. Subject has a history (or family history) of congenital prolonged QTc (corrected QT interval) syndrome or has an abnormal clinically significant electrocardiogram (ECG) at screening, including QTcB (QT interval corrected for heart rate using Bazett's formula) value >450 msec (males) or >470 msec (females); or shows evidence of clinically significant rhythm abnormality.
  6. Subject has a known hypersensitivity to TD-4208 or similar drug class.
  7. Subject has a history of alcoholism or drug abuse within 2 years prior to screening.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Experimental: Dose 1 TD-4208
22 µg
Drug: TD-4208
Other Names:
  • revefenacin
Experimental: Dose 2 TD-4208
44 µg
Drug: TD-4208
Other Names:
  • revefenacin
Experimental: Dose 3 TD-4208
88 µg
Drug: TD-4208
Other Names:
  • revefenacin
Experimental: Dose 4 TD-4208
175 µg
Drug: TD-4208
Other Names:
  • revefenacin
Experimental: Dose 5 TD-4208
350 µg
Drug: TD-4208
Other Names:
  • revefenacin
Experimental: Dose 6 TD-4208
700 µg
Drug: TD-4208
Other Names:
  • revefenacin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline to Day 7 in Trough FEV1 (Forced Expiratory Volume in 1 Second)
Time Frame: From baseline to day 7
From baseline to day 7

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: From baseline to day 7

Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.

Day 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours.
From baseline to day 7
Tmax
Time Frame: From baseline to day 7

Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.

Day 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours.
From baseline to day 7
Plasma Half-life
Time Frame: From baseline to day 7

Day 1: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, and 6 hours.

Day 7: 15 minutes pre-dose, post-dose at 15 and 30 minutes, 1, 2, 3, 4, 6, 8, 12 and 24 hours.
From baseline to day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mylan Inc.

Collaborators

Theravance Biopharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 4, 2012

First Submitted That Met QC Criteria

October 9, 2012

First Posted (Estimate)

October 11, 2012

Study Record Updates

Last Update Posted (Actual)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 22, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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