Anti-platelet Effects of Colchicine in Healthy Volunteers

Study Overview
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Brief Summary
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This is a pilot study. Volunteers will be given 1.8 mg (1.2 mg followed by 0.6 mg one hour later), 1.2 mg, or 0.6 mg of colchicine. Blood will be collected prior to drug administration, 2 hours after colchicine administration, and 24 hours after colchicine administration via the antecubital vein and evaluated for markers of platelet activity and inflammation.

Official Title
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Anti-platelet Effects of Colchicine in Healthy Volunteers

Conditions
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Healthy

Intervention / Treatment
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* Drug: Colchicine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must be more than 18 years of age Exclusion Criteria: 1) history of cardiovascular disease, including myocardial infarction, history of percutaneous coronary angioplasty or stent, peripheral vascular disease or stroke; 2) history of myelodysplasia; 3) medications known to affect platelet function, including non-steroidal anti-inflammatory drugs, antihistamines, and selective serotonin reuptake inhibitors, during the 5 days prior to participation; 4) medications known to interact with colchicine; 5) history of intolerance to colchicine; 6) acute or chronic symptoms of diarrhea, nausea, or vomiting within 1 month prior to enrollment; 7) known anemia or hemoglobin <10mg/dL; 8) platelet count <100,000 or > 450,000; 9) creatinine clearance <30cc/minute; 10) any known hemorrhagic diathesis; 11) pregnant; 12) Unable to consent; or 13) Participating in a competing study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volunteer group<br>Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later | Drug: Colchicine<br>* Colchicine 1.2 mg followed by 0.6 mg one hour later<br>* Other names: Colcrys;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocyte Platelet Aggregate: Baseline |  | Baseline | 
| Monocyte Platelet Aggregate: 2 Hours |  | 2 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Light Transmission Aggregometry: Baseline | In response to adenosine diphosphate | Baseline | 
| Light Transmission Aggregometry: 2 Hours | In response to adenosine diphosphate | 2 hours | 
| Light Transmission Aggregometry: Baseline | In response to adenosine epinephrine | baseline | 
| Light Transmission Aggregometry: 2 Hours | In response to adenosine epinephrine | 2 hours | 
| Platelet Adhesion: Baseline |  | Baseline | 
| Platelet Adhesion: 2 Hours |  | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colchicine, platelet activity, neutrophil