Status:
COMPLETED
A Study to Assess the PK and Safety of PT010 in Subjects With COPD Following Single and Repeat Dose
Lead Sponsor:
Pearl Therapeutics, Inc.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE1
Brief Summary
This is a Phase I open-label, single center study to assess the PK and safety of BGF MDI 320/14.4/9.6 µg in subjects with moderate to severe COPD. Pharmacokinetics will be assessed following a single ...
Eligibility Criteria
Inclusion
- Key
- Given their signed written informed consent to participate.
- Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
- Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS), or other local applicable guidelines.
- Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
- Pre-bronchodilator FEV1/FVC ratio must be \<0.70 and pre-bronchodilator FEV1 must be ≥50% and \<80% predicted normal value calculated using National Health and Nutrition Examination Survey (NHANES) III reference equations
- Key
Exclusion
- Significant diseases or conditions to : other than COPD, active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease and uncontrolled sleep apnea .
- Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
- Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
- Subjects who have a history of hypersensitivity to any corticosteroid,
- β2-agonist, muscarinic anticholinergic, or any component of the MDI
- Alpha-1 antitrypsin deficiency as the cause of COPD
Key Trial Info
Start Date :
August 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 7 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03250182
Start Date
August 11 2017
End Date
December 7 2017
Last Update
January 29 2021
Active Locations (1)
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1
Research Site
Clearwater, Florida, United States, 33765