Study to Determine the Amount of Glycopyrrolate Absorbed in the Lungs After Taking the Medicine With a eFlow Nebulizer and Seebri® Breezhaler® With and Without Activated Charcoal in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: SUN-101 via eFlow nebulizer; SUN-101 via eFlow nebulizer with activated charcoal; Seebri® Breezhaler®; Seebri® Breezhaler® with activated charcoal; Glycopyrrolate Injection
Intervention description: 50 mcg glycopyrrolate via Electronic Nebulizer; 50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal; 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI; 63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal; 50 mcg glycopyrrolate via IV
Intervention MeSH terms: Glycopyrrolate; Bromides; Charcoal
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The purpose of this research study is to determine the amount of medicine absorbed in the
      lungs following dosing via eFlow nebulizer and Seebri® Breezhaler® with and without activated
      charcoal in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients 40 to 70 years-old, inclusive.

          2. A clinical diagnosis of moderate to severe COPD according to the GOLD 2014 guidelines.

          3. Current smokers or ex-smokers with at least 10 pack-year smoking history (eg, at least
             1 pack/day for 10 years, or equivalent).

          4. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1 ≥ 30% and ≤ 80%
             of predicted normal during the Screening Period.

          5. Post-bronchodilator (following inhalation of ipratropium bromide) FEV1/FVC ratio ≤
             0.70 during the Screening Period.

          6. Ability to perform reproducible spirometry according to the American Thoracic Society
             (ATS) and/or European Respiratory Society (ERS) guidelines (2005).

          7. Subject, if female ≤ 70 years of age and of child bearing potential, must have a
             negative urine pregnancy test at Visit 1. Females of childbearing potential must be
             instructed to and agree to avoid pregnancy during the study and must use an acceptable
             method of birth control: a) an oral contraceptive, an intrauterine device (IUD),
             implantable contraceptive, transdermal or injectable contraceptive for at least 1
             month prior to entering the study with continued use throughout the study and for
             thirty days following participation; b) barrier method of contraception, eg, condom
             and /or diaphragm with spermicide while participating in the study; and/or c)
             abstinence.

          8. Willing and able to remain at the study site for at least 24 hours for each treatment
             day.

          9. Willing and able to provide written informed consent.

         10. Willing and able to attend all study visits and adhere to all study assessments and
             procedures.

        Exclusion Criteria:

          1. Severe comorbidities including unstable cardiac or pulmonary disease or any other
             medical conditions that would, in the opinion of the Investigator, preclude the
             subject from safely completing the required tests or the study, or is likely to result
             in disease progression that would require withdrawal of the subject, included but not
             limited to the following:

               -  Unstable ischemic heart disease (diagnosis of myocardial infarction or admission
                  for acute coronary syndrome) within 6 months of screening.

               -  Unstable cardiac arrhythmia or heart failure (change in treatment plan) within 6
                  months.

               -  Treatment for diabetes mellitus within 6 months of screening.

          2. Current evidence or history of a clinically significant abnormality of cardiac rhythm
             and/or conduction findings.

          3. Concomitant clinically significant respiratory disease other than COPD (eg, asthma,
             tuberculosis, bronchiectasis, or other non-specific pulmonary disease).

          4. History of malignancy of any organ system treated or untreated within the past 5
             years, with the exception of localized basal cell carcinoma of the skin.

          5. Recent history of COPD exacerbation requiring hospitalization or need for increased
             treatments for COPD within 6 weeks prior to the Screening Period.

          6. Use of daily oxygen therapy > 10 hours per day.

          7. Use of oral, intravenous, or intramuscular steroids within 3 months prior to the
             Screening Period.

          8. Respiratory tract infection within 6 weeks prior to or during the Screening Period.

          9. Significant blood loss (> 500 mL) or donated blood within 60 days preceding screening
             or plans to donate blood within 60 days after completing the study.

         10. History of or clinically significant ongoing bladder outflow obstruction or history of
             catheterization for relief of bladder outflow obstruction within the previous 6
             months.

         11. History of narrow-angle glaucoma.

         12. Prolonged QTc interval (> 450 msec for males and > 470 msec for females) during the
             Screening Period, or history of long QT syndrome.

         13. Recent documented history (previous 12 months) of substance abuse.

         14. .Positive urine drug screen at Visit 1 provided the subject is unable to produce a
             valid medical rationale for the test result (eg, prescription medication).

         15. Positive HbsAg, Hepatitis C antibody, or HIV 1/2 antibody test at Screening.

         16. History of hypersensitivity or intolerance to aerosol medications, β2-agonists,
             anticholinergics, or sympathomimetic amines.

         17. Significant psychiatric disease that would likely result in the subject not being able
             to complete the study, in the opinion of the Investigator.

         18. Participation in another investigational drug study where drug was received within 30
             days prior to the Screening Period, or current participation in another
             investigational drug trial in which study treatment is being administered, including a
             SUN-101 study

         19. Previously received SUN-101 (active treatment; formerly known as EP-101).

         20. Previously received any glycopyrrolate product within 28 days of Screening.

         21. Subject is taking theophylline.