Anti-platelet Effects of Colchicine in Healthy Volunteers

NCT ID: NCT02140372

Last Updated: 2016-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-01-31

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Volunteer group

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

Group Type: EXPERIMENTAL

Colchicine

Intervention Type: DRUG

Colchicine 1.2 mg followed by 0.6 mg one hour later

Interventions

Colchicine

Colchicine 1.2 mg followed by 0.6 mg one hour later

Intervention Type: DRUG

Other Intervention Names

Colcrys

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Binita Shah, MD, MS

Role: PRINCIPAL_INVESTIGATOR

NYU SOM

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

S13-00747

Identifier Type: -

Identifier Source: org_study_id