NCT04355585

Revisiting the Mechanism of the Anti-inflammatory Effect of Colchicine

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

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 be stratified by sex as this may be a factor influencing GDF15 levels. On Day 1, subjects will be admitted on the CCI 9A unit early in the morning, 30 minutes before the study drug administration. They will be asked to fast from midnight before the dose until 2 hours after. Water is allowed during the fasting period. Baseline blood tests will be drawn and a peripheral line will be left in place for further blood draws. A dose of either colchicine or placebo will be administered. Blood samples will be drawn at 2, 4, 6, 8, 10 and 12 hours. The patient will be discharged home after the last blood draw and the removal of the peripheral line. Two other blood draws will be performed using standard procedures at 24 and 48 hours post study drug administration at the research clinic

Conditions

• Colchicine Mechanism of Action

Interventions

Type	Name	Description
DRUG	Colchicine Tablets	1.8mg of Colchicine given over 1 hour (1.2 mg followed by 0.6 mg 1 hour later)
DRUG	Placebo oral tablet	Placebo given over 1 hour (first tablet followed by second tablet 1 hour later)

Timeline

• Start date: 2020-05-06
• Primary completion: 2023-04-01
• Completion: 2023-04-01
• First posted: 2020-04-21
• Last updated: 2022-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study