A Study to Assess the PK and Safety of PT010 in Subjects With COPD Following Single and Repeat Dose
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: PT010
Intervention description: PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations per use as instructed per the protocol.
Intervention MeSH terms: Budesonide; Glycopyrrolate; Formoterol Fumarate
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No

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 dose administration on the first treatment day (Day 1) and will be
      assessed again after 7 days of repeat dosing. This study includes a Screening Period of up to
      28 days and a single Treatment Period of 8 days. A follow-up phone call will be conducted at
      least 5 days but no longer than 7 days after the last dose of study drug.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  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 Criteria:

          -  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