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

Launched by INOVA HEALTH CARE SERVICES · Mar 27, 2020

Keywords

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Eligibility criteria

• 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.