Status:
UNKNOWN
Revisiting the Mechanism of the Anti-inflammatory Effect of Colchicine
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Harvard Medical School (HMS and HSDM)
Conditions:
Colchicine Mechanism of Action
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
We are doing this research study to better understand the mechanism of action of colchicine, a drug commonly prescribed for gout. Precisely, we aim to evaluate the effect of colchicine on a specific p...
Detailed Description
This will be a randomized, placebo-controlled, double-blind, pilot study evaluating the effect of a single FDA-approved dose of colchicine in healthy adults on plasma GDF15 levels. Randomization will ...
Eligibility Criteria
Inclusion
- Participant able to understand and sign the informed consent of the study
- Healthy male or female aged from 18 to 50 years.
- Participant considered healthy after evaluation such as medical history and screening laboratories.
Exclusion
- Pregnant or lactating women
- Use of colchicine within 28 days prior to study drug administration.
- Renal insufficiency (GFR \< 50 mL/min)
- Use of any drug or product known to interact with colchicine including CYP3A4 and/or P-glycoprotein (P-gp) inhibitors in the 14 days prior study drug administration, such as atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, amprenavir, aprepitant, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, cyclosporine and ranolazine. Significant consumption of grapefruit juice can also inhibit CYP3A4. Interactions may also be seen with fibrates (e.g., gemfibrozil), HMG-CoA reductase inhibitors (statins) and digoxin.
- History of colchicine allergy.
Key Trial Info
Start Date :
May 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2023
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT04355585
Start Date
May 6 2020
End Date
April 1 2023
Last Update
March 16 2022
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115