Revisiting the Mechanism of the Anti-inflammatory Effect of Colchicine

• Status: Recruiting
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

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 protein (GDF15) blood levels at different timepoints after its administration.

This research study will compare GDF15 blood levels after the administration of colchicine or placebo. The placebo looks exactly like colchicine but contains no active drug. During this study, participants may get a placebo instead of colchicine. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborators: Harvard Medical School; Harvard Medical School (HMS and HSDM)
• Treatments: Colchicine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.