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Anti-platelet Effects of Colchicine in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02140372
Recruitment Status : Completed
First Posted : May 16, 2014
Results First Posted : February 23, 2016
Last Update Posted : February 23, 2016
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Colchicine Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti-platelet Effects of Colchicine in Healthy Volunteers
Study Start Date : May 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

Arms and Interventions
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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 Name: Colcrys


Outcome Measures
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Primary Outcome Measures :
  1. Monocyte Platelet Aggregate: Baseline [ Time Frame: Baseline ]
  2. Monocyte Platelet Aggregate: 2 Hours [ Time Frame: 2 Hours ]

Secondary Outcome Measures :
  1. Light Transmission Aggregometry: Baseline [ Time Frame: Baseline ]
    In response to adenosine diphosphate

  2. Light Transmission Aggregometry: 2 Hours [ Time Frame: 2 hours ]
    In response to adenosine diphosphate

  3. Light Transmission Aggregometry: Baseline [ Time Frame: baseline ]
    In response to adenosine epinephrine

  4. Light Transmission Aggregometry: 2 Hours [ Time Frame: 2 hours ]
    In response to adenosine epinephrine

  5. Platelet Adhesion: Baseline [ Time Frame: Baseline ]
  6. Platelet Adhesion: 2 Hours [ Time Frame: 2 hours ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02140372


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Binita Shah, MD, MS NYU SOM
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02140372    
Other Study ID Numbers: S13-00747
First Posted: May 16, 2014    Key Record Dates
Results First Posted: February 23, 2016
Last Update Posted: February 23, 2016
Last Verified: January 2016
Keywords provided by NYU Langone Health:
colchicine
platelet activity
neutrophil
Additional relevant MeSH terms:
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Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents