Comparative Pharmacokinetic, Pharmacodynamic, and Safety Study of 1 Dose of Aspirin for Injection… (NCT07323680) | Clinical Trial Compass
By InvitationPhase 1
Comparative Pharmacokinetic, Pharmacodynamic, and Safety Study of 1 Dose of Aspirin for Injection and Oral Aspirin Tablets in Healthy Adult Subjects
Czechia40 participantsStarted 2025-06-15
Plain-language summary
The purpose of this study is to compare the safety, pharmacokinetics, and pharmacodynamic effects of aspirin administered intravenously with aspirin administered orally.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Healthy males and non-pregnant and no breast-feeding females, ≥ 18 and ≤ 55 years of age (on the day of Informed Consent).
✓. Non-smokers or past smokers (having ceased smoking at least 6 months before the first dosing).
✓. Body Mass Index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2 on the day of screening.
✓. The subject is considered by the investigator to be in good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead electrocardiogram (ECG) results, and physical examination findings at Screening.
✓. The subject has a hemoglobin level with the following acceptable range at Screening: (Male: 12.8 to 17.4 g/dL (128 to 174 g/L); Female: 10.8 to 15.0 g/dL (108 to 150 g/L).
✓. The subject has liver function tests within normal limits or has results that do not show clinically significant abnormalities, as judged by the investigator at Screening.
✓. The subject has estimated glomerular filtration rate eGFR (CKD-EPI) ≥50 mL/min (0.833mL/sec/1.73m2) at Screening.
✓. Acceptance of use of contraceptive measures during the whole study by both female and male subjects.
Exclusion criteria
✕. The subjects has had any major illness within 3 months before dosing with study drug or any significant ongoing chronic medical illness, as judged by the investigator.
✕. The subjects has a history of active deep vein thrombosis and/or thromboembolic disorder, including history of hypothrombinemia and vitamin K deficiency.
What they're measuring
1
Change in serum thromboxane B2 from baseline
Timeframe: 1 hour before dosing and 2, 5, 10, 20, 30, 45, 60, and 180 minutes post dosing]
✕. The subject has a history of neuropsychiatric disease, hypertension, cardiac failure, cerebrovascular disease, chronic respiratory disease, asthma, nasal polyps associated with asthma, hepatic or renal impairment, recent dehydration (within last 30 days), gout thyrotoxicosis or systemic lupus erythematosus and other connective tissue disorders.
✕. The subject has a history of gastrointestinal bleeding or has active gastrointestinal disease that could affect drug absorption.
✕. The subject has a history of hemorrhagic disorder.
✕. Prothrombin time or activated partial thromboplastin time level outside the normal range at screening and check-in.
✕. The subject has an increased risk of bleeding including but not limited to: any history of a clinically significant bleeding problem, any recent (within 30 days preceding the first dose of study drug) major trauma, platelet count \<100,000 mm3
✕. The subject has a history of glucose-6-phosphate dehydrogenase deficiency.