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OpenTrials
Completed

NCT Number: NCT02140372

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New York University School of Medicine

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects must be more than 18 years of age

Exclusion criteria

  • 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.

Treatment and study plan

Colchicine

Drug

Colchicine 1.2 mg followed by 0.6 mg one hour later

Other names: Colcrys

Primary outcomes

  1. Monocyte Platelet Aggregate: Baseline

    Time frame: Baseline

  2. Monocyte Platelet Aggregate: 2 Hours

    Time frame: 2 Hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 16, 2014
Registry last updated
Feb 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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