A Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to Assess the Relative Bioavailability of PT010
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Regimen A; Regimen B; Regimen C; Regimen D
Intervention description: 2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure; 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure; 2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure; 2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 56.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: COPD

Summary:

      Randomized, Open-label, Single-dose, Single-center, Crossover Study in Healthy Subjects to
      Assess the Relative Bioavailability of PT010
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Signed and dated Independent Ethics Committee (IEC)/Institutional Review Board
             (IRB)-approved Informed Consent Form (ICF) before any protocol-specific screening
             procedures are performed

          -  Male and female subjects 18 to 40 years of age, inclusive

          -  Be in good general health as determined by a thorough medical history and physical
             examination, ECG, vital signs, and clinical laboratory evaluation

          -  Non-childbearing potential (ie, physiologically incapable of becoming pregnant,
             including any female who is 2 years post-menopausal, or surgically sterile

          -  Male subjects who are sexually active must agree to use a double-barrier method of
             contraception (condom with spermicide) from the first dose of randomized study drug
             until 2 weeks after their last dose, and must not donate sperm during their study
             participation period

          -  Screening laboratory tests must be within normal range or determined to not be
             clinically significant by the Investigator.

          -  Demonstrate correct MDI administration technique

        Key Exclusion Criteria:

          -  For female subjects, a positive serum human chorionic gonadotropin (hCG) test at
             screening or a positive urine hCG at admission for any of the 4 Treatment Periods

          -  Subjects with clinically significant neurologic, cardiovascular, hepatic, renal,
             endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that
             would interfere with participation in this study

          -  Subjects who have cancer that has not been in complete remission for at least 5 years

          -  Male subjects with a trans-urethral resection of the prostate or full resection of the
             prostate within 6 months prior to screening

          -  Subjects with bladder neck obstruction or urinary retention that is clinically
             significant in the opinion of the Investigator

          -  History of substance-related disorders (with the exception of caffeine-related and
             nicotine-related disorders) within 1 year of screening

          -  History of smoking or the use of nicotine-containing products within 3 months of
             screening by self-reporting

          -  A positive alcohol breathalyzer or urine drug screen for drugs of abuse at screening
             or at the beginning of each Treatment Period

          -  Treatment with any prescription or non-prescription drugs including vitamins, herbal,
             and dietary supplements for 28 days or 5 half-lives, whichever is longer, before study
             drug use

          -  Treatment with an investigational drug within 30 days or 5 half-lives (whichever is
             longer) prior to the beginning of the screening Period

          -  Subjects with any flu-like syndrome or other respiratory infections within 2 weeks of
             drug administration or who have been vaccinated with an attenuated live virus within 4
             weeks of drug administration

          -  Any other condition and/or situation that causes the Investigator to deem a subject
             unsuitable for the study (eg, inability to medically tolerate the study procedures, or
             a subject's unwillingness to comply with study-related procedures)