Anti-platelet Effects of Colchicine in Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Colchicine

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Volunteer group; Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later	Drug: Colchicine; Colchicine 1.2 mg followed by 0.6 mg one hour later; Other Names: Colcrys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Binita Shah, MD, MS, NYU SOM

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: May 14, 2014
• First Submitted That Met QC Criteria: May 15, 2014
• First Posted (Estimate): May 16, 2014

Study Record Updates

• Last Update Posted (Estimate): February 23, 2016
• Last Update Submitted That Met QC Criteria: January 26, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: platelet activity; neutrophil; colchicine
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Gout Suppressants; Colchicine
• Other Study ID Numbers: S13-00747