Revisiting the Mechanism of the Anti-inflammatory Effect of Colchicine

NCT04355585 | Unknown Phase 1 FDA Drug

• 1 other identifier: 2020P000440
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Colchicine Mechanism of Action

Keywords

pharmacology

Outcome Measures

Primary Outcomes (1)

• Plasma GDF15 levels

  The primary endpoint will be the plasma GDF15 level before and at different timepoints after colchicine administration. Plasma GDF-15 level will be determined using an enzyme immunoassay (EIA) testing.

  Before product administration and 2, 4, 6 ,8, 10,12, 24 and 48 hours after product administration

Study Arms (2)

Male

EXPERIMENTAL

Participants in this group will be randomized to receive either a single dose of colchicine (1.8mg administered over 1 hour in the form of tablets) or placebo.

Drug: Colchicine Tablets; Drug: Placebo oral tablet

Female

EXPERIMENTAL

Participants in this group will be randomized to receive either a single dose of colchicine (1.8mg administered over 1 hour in the form of tablets) or placebo.

Drug: Colchicine Tablets; Drug: Placebo oral tablet

Interventions

Colchicine Tablets DRUG

1.8mg of Colchicine given over 1 hour (1.2 mg followed by 0.6 mg 1 hour later)

Female; Male

Placebo oral tablet DRUG

Placebo given over 1 hour (first tablet followed by second tablet 1 hour later)

Female; Male

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Lindsey Baden, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsey Baden, MD

CONTACT

978-VACCINE; vaccines@partners.org

Jessica Cauley

CONTACT

6177325394; jcauley@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study in which investigators, participants, site personnel, and laboratory staff will be blinded during the study. Only the research pharmacy will have access to randomization and treatment assignments.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: Stratified randomization according to sex will be performed. Each group will be randomized to receive colchicine or placebo.

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: April 21, 2020
• Study Start: May 6, 2020
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)