Healthy subjects study design

We conducted a prospective study of healthy adults with no chronic medical problems or current prescription medication use. Exclusion criteria included the following: (1) history of cardiovascular disease; (2) history of myelodysplasia; (3) use of medications (prescription or over the counter) known to affect platelet function, including non-steroidal anti-inflammatory drugs, anti-histamines, and selective serotonin reuptake inhibitors within 5 days of study procedures; (4) history of intolerance to colchicine; (5) symptoms of acute or chronic diarrhea, nausea or vomiting within 1 month of study procedures; (6) known anemia or hemoglobin <10 mg/dL; (7) platelet count <100,000 or >450,000 K/μL; (8) creatinine clearance <30 cc/minute; (9) any known hemorrhagic diathesis; (10) current pregnancy; or (11) participation in a competing study. The study is registered at ClinicalTrials.gov (identifier: {"type":"clinical-trial","attrs":{"text":"NCT02140372","term_id":"NCT02140372"}}NCT02140372). The study was approved by the New York University School of Medicine Institutional Review Board and all subjects provided written informed consent.

Demographic information was self-reported. Height, weight, and abdominal circumference were measured by trained research nurses or assistants. Pertinent medical history was obtained from subject interview and questionnaire. Subjects fasted overnight and refrained from intensive exercise and tobacco use for 8 hours prior to study procedures. Phlebotomy was performed via standard venipuncture with a 19-guage needle. After a 2 cc discard, blood was collected in 3.2% (0.109 mol/L) sodium citrate tubes (BD Vacutainer, 2.7 mL). Colchicine tablets (0.6 mg) were obtained from the New York University Clinical Translational Science Institute investigational pharmacy. After obtaining a baseline blood sample, subjects were administered 1.2 mg colchicine by mouth followed by 0.6 mg colchicine by mouth 1 hour later. Subsequent blood samples were drawn 2 and 24 hours after completion of the 1.8 mg colchicine loading dose.