Pharmacodynamics and Pharmacokinetics of Aspirin Inhalation Powder With Non-Enteric-Coated Chewable Aspirin

This is an interventional treatment trial for Platelet Aggregation Inhibitors Read More

Inclusion Criteria:

• Male or female subjects, 18-55 years of age
• Non-smokers
• Body mass index (BMI) within 18.5 kg/m2 to 32.0 kg/m2
• Female subjects of childbearing potential must agree to use acceptable methods of birth control or abstain from sex during study participation and must have a negative serum or urine pregnancy test
• Subjects must be healthy as determined by medical history, physical examination, vital signs, and clinical laboratory evaluation
• Signed informed consent

Exclusion Criteria:

• At screening visit, subjects with a forced expiratory volume in 1 second (FEV1) (i.e., FEV1% predicted < 80%).
• At screening visit, subjects with a forced expiratory flow at 25%-75% (FEF 25%-75%) of pulmonary volume < 70% predicted.
• Patients with a flow rate <70 L/min with a G-16 training device set at medium resistance.
• Hematocrit value ≤32%
• Clinically significant hemoglobin value, at screening, as per investigator.
• Arachidonic acid induced-maximum platelet aggregation <50%.
• Platelet count <142,000 or > 450,000 µL.
• Presence of any tongue piercings or history of any tongue piercings in the last 90 days prior to the first study drug administration.
• Presence of braces, partials or dentures.
• Clinically significant abnormal laboratory parameters.
• Antiplatelet agents (ASA, NSAID's, P2Y12 inhibitors, etc.) within 10 days of dosing visit.
• HIV, hepatitis B or C infection.
• Presence of clinically significant cardiovascular, pulmonary, hepatic, renal, endocrinological, hematological, immunologic, metabolic, neurological, or gastrointestinal disease.
• Clinically significant physical examination.
• History of hypersensitivity or allergy to aspirin.
• History of significant bleeding disorders.
• History of peptic ulcer disease.
• History of asthma or chronic obstructive pulmonary disease.
• Concurrent corticosteroid use with the exception of topical; any previous use must have occurred at least 90 days prior to Day 1 of the study and be approved by the Investigator.
• Administration of any prescription/over the counter medications/herbal/nutritional supplements within 14 days that has an effect on platelets prior to visit1 of the study.
• Administration of any investigational drug product (IP) within 30 days prior to visit 1.
• ALT ≥ 3xULN.
• Total Bilirubin > 1.5x ULN (isolated bilirubin > 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin < 35%).
• Donation of blood or platelets within 60 days prior to visit 1.
• Any condition, illness, or disease that in the opinion of the investigator would interfere with the subject's ability to comply with the requirements of this protocol.