Study to Evaluate Single Inhaled Doses of PT001, PT003, PT005 and PT001 Plus PT005 in Healthy Subjects
Condition: Healthy Volunteers
Intervention: PT001; PT005; PT003; PT001 + PT005
Intervention description: Inhaled PT001, single dose; Inhaled PT005, single dose; Inhaled PT003, single dose; Inhaled PT001 + PT005, single dose
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Healthy Volunteers

Summary:

      The purpose of this study is to evaluate the safety of a single dose of PT003 compared with
      single doses of PT001 and PT005, and compared with PT001 plus PT005 delivered together as two
      separate single doses in healthy subjects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide signed written informed consent

          -  18-55 years of age

          -  Healthy subjects confirmed by medical history, physical examination, vital signs,
             pulmonary function tests, electrocardiogram and clinical laboratory tests

          -  Female subjects of child-bearing potential who are sexually active must be willing to
             undergo a pregnancy test and agree to use two forms of contraception

          -  Body mass index (BMI) between 18.5 and 30, inclusive

          -  Non-smokers for at least 6 months prior to screening

          -  Pulmonary function tests within normal limits

          -  Willing to remain at the study center for at least 12-24 hours on each test day

          -  Venous access in both arms to allow collection of numerous blood samples

        Exclusion Criteria:

          -  Women who are pregnant or lactating

          -  Clinically significant medical conditions

          -  Viral illness within the last 30 days

          -  Symptomatic prostatic hypertrophy or bladder neck obstruction

          -  Known narrow-angle glaucoma

          -  History of bowel obstruction

          -  Clinically significant abnormal electrocardiogram

          -  Positive Hepatitis B surface antigen or positive Hepatitis C antibody

          -  Positive screening test for HIV antibodies

          -  History of hypersensitivity to any beta2-agonists, anticholinergics, or any component
             of the MDI

          -  Known or suspected history of alcohol or drug abuse within the last 2-years

          -  Greater than normal alcohol consumption

          -  Ingestion of any poppy seeds within the 48 hours prior to the screening

          -  Ingestion of any poppy seeds within the 48 hours prior to, or any alcohol, xanthines
             or grapefruit-containing foods or beverages within the 24 hours prior to, or during,
             each confinement

          -  Positive breath alcohol result

          -  Positive urine drug screen

          -  Use of any beta2-agonists,or anticholinergics prior to the recruitment interview

          -  Lower respiratory tract infections requiring antibiotics in the previous 6 weeks

          -  Use of any other prescription medication

          -  Use of any over the counter product, herbal product, diet aid, hormone supplement

          -  Donation > 450 ml of blood within 8 weeks of first treatment dose

          -  Clinically significant vital sign abnormality

          -  Clinically significant biochemical, hematological or urinalysis abnormality

          -  Affiliations with investigator site

          -  Treatment with investigational study drug or participation in another clinical trial
             or study within the last 30 days or 5 half lives prior to screening, whichever is
             longer