The goal of this clinical trial is to compare the pharmacokinetics (PK) pharmacodynamics (PD), safety and tolerability of acetylsalicylic acid powder for oral inhalation (I-ASA) with non-enteric-coated chewable aspirin (C-ASA) in adult subjects with obstructive or restrictive pulmonary function. In the first treatment period, subjects will be randomized to receive either a single dose (100 mg) of I-ASA powder via a Dry Powder Inhaler (DPI) OR a single dose (162 mg) of C-ASA tablets. After a washout period, subjects will be crossed over to receive the other treatment in the second treatment period. All subjects will receive both treatments during the study. Each single dose treatment will be followed by up to 24 hours of serial post-dose PK, PD, and safety/tolerability assessments.
Up to 16 adult males and females subjects are planned for enrollment in this study, to achieve a minimum of 10 subjects with evaluable PD/PK, safety, and tolerability data: * 5 subjects with obstructive lung function \[i.e., diagnosed with chronic obstructive pulmonary disease (COPD)\]; and * 5 subjects with restrictive lung function
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4
powder for oral inhalation via a Dry Powder Inhaler (DPI)
orally administered
Omega Research Orlando, LLC
Orlando, Florida, United States
Clinical Site Partners, LLC CSP Orlando
Winter Park, Florida, United States
Sinai Hospital
Baltimore, Maryland, United States
Hassman Research Institute
Berlin, New Jersey, United States
Peak plasma concentration of ASA (Cmax)
Time frame: pre-dose and 24 hours post-dose
Area under the ASA plasma concentration versus time curve (AUC0-inf)
Time frame: pre-dose and 24 hours post-dose
Area under the ASA plasma concentration versus time curve (AUC0-t)
Time frame: pre-dose and 24 hours post-dose
Tmax of plasma concentrations of ASA.
Time frame: assessed up to 24 hours post-dose
Tmax of plasma concentrations of SA.
Time frame: assessed up to 24 hours post-dose
Peak Plasma Concentration (Cmax) of SA.
Time frame: minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 240, 360, 480, 720
Area under the plasma concentration versus time curve (AUC0-inf) of SA.
Time frame: minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 240, 360, 480, 720
Area under the plasma concentration versus time curve (AUC0-t) of SA.
Time frame: minutes post-dose: 2, 5, 10, 20, 30, 45, 60, 120, 180, 240, 360, 480, 720
Serum thromboxane B2 (TxB2) serum concentration - Area under the effect curve (AUEC) of the % Change from baseline (CFB) in serum TxB2 concentration (TxB2 suppression).
Time frame: 24 hours post-dose
TxB2 serum concentration - AUEC of the % CFB in serum TxB2 concentration (TxB2 suppression).
Time frame: 20 minutes post-dose
TxB2 serum concentration - AUEC of the % CFB in serum TxB2 concentration (TxB2 suppression)
Time frame: 30 minutes post-dose
Proportion of subjects achieving significant inhibition of platelet aggregation (<550 Aspirin Reaction Units [ARU])
Time frame: 2 minutes
Time to significant reduction in platelet aggregation (<550 ARU)
Time frame: assessed up to 24 hours post-dose
Time to half-maximal % inhibition (suppression) of serum TxB2 (ID-50).
Time frame: assessed up to 24 hours post-dose
Time to maximum % inhibition of serum TxB2.
Time frame: assessed up to 24 hours post-dose
Time to maximum inhibition of platelet aggregation, assessed by VerifyNow Aspirin test.
Time frame: assessed up to 24 hours post-dose
Maximum % CFB in ARU assessed by VerifyNow tests.
Time frame: assessed up to 24 hours post-dose
Maximum % CFB in urinary 11-dehydro-TxB2.
Time frame: assessed up to 24 hours post-dose
Maximum % CFB in serum 6-keto-PGF1α levels.
Time frame: assessed up to 24 hours post-dose
Incidence and frequency of adverse events
Time frame: Screening through the 7-day follow-up period
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