Ignite Creation Date:
2024-05-06 @ 2:34 PM
Last Modification Date:
2024-10-26 @ 1:33 PM
Study NCT ID:
NCT04355585
Status:
UNKNOWN
Last Update Posted:
2022-03-16
First Post:
2020-04-18
Brief Title:
Revisiting the Mechanism of the Anti-inflammatory Effect of Colchicine
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Revisiting the Mechanism of the Anti-inflammatory Effect of Colchicine
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None