Phase 4
Completed N=10
Anti-platelet Effects of Colchicine in Healthy Volunteers
Healthy
Source: ClinicalTrials.gov NCT02140372 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: Monocyte Platelet Aggregate: Baseline — 27.8 percentage of monocyte-platelet aggregat
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monocyte Platelet Aggregate: Baseline |
27.8 | — |
| PRIMARY Monocyte Platelet Aggregate: 2 Hours |
22 | — |
| SECONDARY Light Transmission Aggregometry: Baseline |
84.9 | — |
| SECONDARY Light Transmission Aggregometry: 2 Hours |
84.6 | — |
| SECONDARY Platelet Adhesion: Baseline |
10.2 | — |
| SECONDARY Platelet Adhesion: 2 Hours |
2.0 | — |
Eligibility Criteria
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 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.
Data sourced from ClinicalTrials.gov (NCT02140372). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.