Healthy Volunteers
Conditions
Brief summary
This study will evaluate whether the antiplatelet effects of Aspirin 300 mg daily and Clopidogrel 75 mg daily can be reproducibly measured using several point of care platelet function assays
Interventions
DRUGPlacebo (to match Aspirin)
Placebo grossly matched Aspirin 300 mg daily
DRUGAspirin
Aspirin 300 mg daily
DRUGClopidogrel
Clopidogrel 75 mg daily
DRUGComparator: Placebo (to match Clopidogrel)
Placebo (grossly matched Clopidogrel 75 mg) daily
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject has BMI (Body Mass Index) less than 32 kg/m\^ 2 * Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 3 months * Subject does not have a history of any bleeding disorder
Exclusion criteria
* Subject is a pregnant or nursing female * Subject has a history of multiple and/or severe allergies to drugs or foods, or any history (personal or family) of bleeding disorders (including arterial bleeding, hemorrhage requiring transfusion or urgent intervention) * Subject currently uses on a regular basis or has used aspirin or clopidogrel within 21 days prior to screening (including low-dose aspirin and pain relievers, cold, or sinus remedies containing aspirin) * Subject currently uses on a regular basis or has used within 2 weeks prior to study start, any other prescription or nonprescription drugs, including NSAIDs such as ibuprofen, naproxen, COX-II inhibitors such as celecoxib or etoricoxib, other pain relievers, cold, or sinus remedies containing NSAIDs, and herbal remedies (e.g., St. John Wort) * Subject anticipates needing during the study any prescription or nonprescription (including over the counter) preparation, including those that contain aspirin, ibuprofen, or any other NSAID or NSAID-containing product commonly found in pain relievers, cold or sinus remedies * Subject has a history of skin conditions (such as dry skin, pruritus, rosacea, eczema) or has a sun burn at the time of screening and is unwilling to avoid excessive sun exposure for the duration of the study * Subject regularly uses antacids or other OTC medications (4 or more times per month) for symptoms of dyspepsia or has a history of use of prescription ulcer medication such as H2 blockers (e.g., cimetidine, ranitidine, famotidine, nizatidine) or a proton pump inhibitor (omeprazole) within the last 5 years * Subject has a history of poor wound healing or a tendency to form keloids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effect size of light transmission platelet aggregation, bleeding time, and several point of care platelet function assays after 3 days of administration of study drug compared to placebo treatment. | Baseline and 3 days |
| The intra-subject coefficient of variation of each of the 3 platelet function devices | Baseline and 3 days |
Outcome results
None listed