Anti-platelet Effects of Colchicine in Healthy Volunteers

Phase 4

Completed

• Conditions: Healthy
• Interventions: Drug: Colchicine

• Registration Number: NCT02140372
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-14
• Study First Submitted QC: 2014-05-15
• Study First Posted: 2014-05-16
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-01
• Results First Submitted: 2016-01-26
• Results First Submitted QC: 2016-01-26
• Last Update Submitted: 2016-01-26
• Results First Posted: 2016-02-23
• Last Update Posted: 2016-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Volunteer group	Colchicine	Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later

Primary Outcome Measures

Name	Time	Method
Monocyte Platelet Aggregate: Baseline	Baseline
Monocyte Platelet Aggregate: 2 Hours	2 Hours

Secondary Outcome Measures

Name	Time	Method
Platelet Adhesion: 2 Hours	2 hours
Light Transmission Aggregometry: 2 Hours	2 hours	In response to adenosine epinephrine
Platelet Adhesion: Baseline	Baseline
Light Transmission Aggregometry: Baseline	baseline	In response to adenosine epinephrine

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States