Pharmacodynamics and Pharmacokinetics of Aspirin Inhalation Powder With Non-Enteric-Coated Chewable Aspirin
Status:
Completed
Trial end date:
2019-10-10
Target enrollment:
Participant gender:
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 infarction (MI), an FDA approved indication for oral formulations of
aspirin.
The primary goal of study OTP-P0-926 is to collect pharmacokinetic (PK)and pharmacodynamics
(PD) pilot data to determine onset and extent of aspirin response after administration of
varying doses of inhaled ASA (50-100mg) and 162 mg Non-Enteric-Coated Chewable ASA. PD will
be assessed using standard methods to measure platelet inhibition by aspirin including
platelet aggregation, serum thromboxane,and urinary thromboxane. Furthermore, the
pharmacokinetics (PK) of ASA will be determined and compared to PD measurements. Results of
this pilot study will guide dosing in a subsequent larger Phase II study.