Status:
COMPLETED
Pharmacodynamics and Pharmacokinetics of Aspirin Inhalation Powder With Non-Enteric-Coated Chewable Aspirin
Lead Sponsor:
Inova Health Care Services
Conditions:
Platelet Aggregation Inhibitors
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
ASA inhalation powder is an inhaled nonsteroidal anti-inflammatory drug-device combination that has been developed to reduce the risk of vascular mortality in patients with suspected acute myocardial ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 10 2019
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04328883
Start Date
July 16 2019
End Date
October 10 2019
Last Update
April 1 2020
Active Locations (1)
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1
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042