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

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ClinicalTrials.gov Identifier: NCT01704404

Recruitment Status : Completed

First Posted : October 11, 2012

Results First Posted : March 13, 2017

Last Update Posted : February 24, 2022

Sponsor:

Collaborator:

Theravance Biopharma

Information provided by (Responsible Party):

Viatris Inc. ( Mylan Inc. )

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
COPD	Drug: TD-4208 Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	62 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	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
Study Start Date :	December 2012
Actual Primary Completion Date :	November 2013
Actual Study Completion Date :	December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Dose 1 TD-4208 22 µg	Drug: TD-4208 Other Name: revefenacin
Experimental: Dose 2 TD-4208 44 µg	Drug: TD-4208 Other Name: revefenacin
Experimental: Dose 3 TD-4208 88 µg	Drug: TD-4208 Other Name: revefenacin
Experimental: Dose 4 TD-4208 175 µg	Drug: TD-4208 Other Name: revefenacin
Experimental: Dose 5 TD-4208 350 µg	Drug: TD-4208 Other Name: revefenacin
Experimental: Dose 6 TD-4208 700 µg	Drug: TD-4208 Other Name: revefenacin
Placebo Comparator: Placebo Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

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

Other Outcome Measures:

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.
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.
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.

Eligibility Criteria

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Ages Eligible for Study:	40 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject is a male or female between the ages of 40 and 75 years (inclusive, at randomization).
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.
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.
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.
Subject (or care giver) is able to properly prepare and administer study medication.
Subject is willing and able to give written informed consent to participate.

Exclusion Criteria:

Subject has had a COPD exacerbation or lung infection within 6 weeks before randomization.
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.
Subject is taking daily maintenance inhaled/systemic corticosteroids (>1000 μg of fluticasone propionate equivalent or ≥10 mg prednisone).
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.
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.
Subject has a known hypersensitivity to TD-4208 or similar drug class.
Subject has a history of alcoholism or drug abuse within 2 years prior to screening.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01704404

Locations

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New Zealand
P3 Research Ltd
Wellington, New Zealand

Sponsors and Collaborators

Mylan Inc.

Theravance Biopharma

Investigators

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Study Director:	Medical Monitor	Theravance Biopharma

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lo A, Borin MT, Bourdet DL. Population Pharmacokinetics of Revefenacin in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2021 Mar;60(3):391-401. doi: 10.1007/s40262-020-00938-3.

Quinn D, Barnes CN, Yates W, Bourdet DL, Moran EJ, Potgieter P, Nicholls A, Haumann B, Singh D. Pharmacodynamics, pharmacokinetics and safety of revefenacin (TD-4208), a long-acting muscarinic antagonist, in patients with chronic obstructive pulmonary disease (COPD): Results of two randomized, double-blind, phase 2 studies. Pulm Pharmacol Ther. 2018 Feb;48:71-79. doi: 10.1016/j.pupt.2017.10.003. Epub 2017 Oct 4.

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Responsible Party:	Mylan Inc.
ClinicalTrials.gov Identifier:	NCT01704404
Other Study ID Numbers:	0091
First Posted:	October 11, 2012 Key Record Dates
Results First Posted:	March 13, 2017
Last Update Posted:	February 24, 2022
Last Verified:	February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Viatris Inc. ( Mylan Inc. ):


Long acting muscarinic antagonist Chronic Bronchitis Emphysema Chronic Obstructive Pulmonary Disease COPD

Additional relevant MeSH terms:

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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

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