Healthy
Conditions
Keywords
colchicine, platelet activity, neutrophil
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.
Interventions
DRUGColchicine
Colchicine 1.2 mg followed by 0.6 mg one hour later
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Monocyte Platelet Aggregate: Baseline | Baseline |
| Monocyte Platelet Aggregate: 2 Hours | 2 Hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Light Transmission Aggregometry: Baseline | Baseline | In response to adenosine diphosphate |
| Light Transmission Aggregometry: 2 Hours | 2 hours | In response to adenosine diphosphate |
| Platelet Adhesion: Baseline | Baseline | — |
| Platelet Adhesion: 2 Hours | 2 hours | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Volunteer Group Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later
Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Volunteer Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 7 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Monocyte Platelet Aggregate: 2 Hours
Time frame: 2 Hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Volunteer Group | Monocyte Platelet Aggregate: 2 Hours | 22 percentage of monocyte-platelet aggregat |
Primary
Monocyte Platelet Aggregate: Baseline
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Volunteer Group | Monocyte Platelet Aggregate: Baseline | 27.8 percentage of monocyte-platelet aggregat |
Secondary
Light Transmission Aggregometry: 2 Hours
In response to adenosine epinephrine
Time frame: 2 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Volunteer Group | Light Transmission Aggregometry: 2 Hours | 84.6 percentage of max platelet aggregation |
Secondary
Light Transmission Aggregometry: 2 Hours
In response to adenosine diphosphate
Time frame: 2 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Volunteer Group | Light Transmission Aggregometry: 2 Hours | 66.6 percentage of max platelet aggregation |
Secondary
Light Transmission Aggregometry: Baseline
In response to adenosine epinephrine
Time frame: baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Volunteer Group | Light Transmission Aggregometry: Baseline | 84.9 percentage of max platelet aggregation |
Secondary
Light Transmission Aggregometry: Baseline
In response to adenosine diphosphate
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Volunteer Group | Light Transmission Aggregometry: Baseline | 48.7 percentage of max platelet aggregation |
Secondary
Platelet Adhesion: 2 Hours
Time frame: 2 hours
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Volunteer Group | Platelet Adhesion: 2 Hours | 2.0 percentage of adhered platelets |
Secondary
Platelet Adhesion: Baseline
Time frame: Baseline
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Volunteer Group | Platelet Adhesion: Baseline | 10.2 percentage of adhered platelets |