Anti-platelet Effects of Colchicine in Healthy Volunteers

NYU Langone Health

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT02140372

S13-00747

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Volunteer group

Experimental group

Description:

Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later

Treatment:

Drug: Colchicine