Clinical trials: Colchicine
Hypertriglyceridemia, Gout
Apolipoprotein CIII Reduction Via Colchicine
The aim of this trial will be to determine an effect-size for the administration of chronic low-dose colchicine in the reduction of serum levels of triglycerides (TG), very-low density lipoproteins (VLDL), and apolipoprotein CIII…
- Conditions
- Hypertriglyceridemia, Gout, Pericarditis
- Trial name
- NCT02083510
- Testing
- Colchicine
- Where
- United States
- Volunteers
- 5 people, healthy volunteers welcome
- Sponsor
- Scripps Translational Science Institute
Healthy
Drug-Food Interaction Study of Seville Orange Juice and Colchicine
Seville orange juice is an inhibitor of the intestinal cytochrome P450 (CYP) 3A4 enzyme, one of the enzymes responsible for the metabolism of colchicine.
- Trial name
- NCT00960193
- Testing
- Colchicine, Seville Orange Juice
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Relative Bioavailability of Colcrys™ 0.6 mg Tablets in Healthy Young and Elderly Volunteers Under Fasted Conditions
The purpose of this study is to evaluate and compare the relative bioavailability of a single dose of Colcrys™ (colchicine) 0.6 mg when administered to a group of young , healthy subjects 18-30 years of age compared to a group of…
- Trial name
- NCT01001052
- Testing
- Colcrys™ (colchicine)
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy; Adult; Volunteer; Colchicine; Pharmacokinetics; Diltiazem; Cytochrome p450 3A4; P-glycoprotein
Drug-Drug Interaction Study Between Colchicine and Diltiazem ER
Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp). Extended-release diltiazem (diltiazem ER) is a potent inhibitor of both CYP3A4 and P-gp.
- Trial name
- NCT00983372
- Testing
- Colchicine, Diltiazem ER
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Pharmacokinetics
Pharmacokinetic Study With Colchicine in Healthy Volunteers
This open label, single group, sequential dose study will compare the single dose pharmacokinetics of colchicine 0.6 mg given orally to colchicine pharmacokinetics after 10 days of a standard prophylactic dose (0.6 mg every 12…
- Trial name
- NCT01017003
- Testing
- colchicine tablets
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Bioavailability Study of Colcrys® in Apple Juice
The purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of Colcrys® (colchicine, USP) when crushed and dissolved in apple juice relative to the same dose given as an intact…
- Trial name
- NCT01123395
- Testing
- colchicine 0.6 mg tablet
- Where
- United States
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Pharmacokinetics
Healthy and Renal Impairment Study of Colcrys (Colchicine, USP)
The primary objective of this study is to compare the pharmacokinetic profiles of colchicine and its primary metabolites in plasma and urine following a single 0.6 mg oral dose of colchicine in healthy adults with normal renal…
- Trial name
- NCT01084278
- Testing
- Colchicine
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Takeda
Pharmacokinetics
Drug-Drug Interaction Study of Colchicine and Azithromycin
Azithromycin is a possible weak to moderate inhibitor of CYP3A4, one of the enzymes responsible for the metabolism of colchicine.
- Trial name
- NCT00983294
- Testing
- Colchicine, Azithromycin
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Healthy
Drug Interaction Study of Colchicine and Theophylline
Colchicine is a supressor of hepatic CYP1A2 and theophylline is a sensitive CYP1A2 probe substrate. When the two are co-administered the potential exists for a clinically significant drug interaction.
- Trial name
- NCT01601132
- Testing
- theophylline, colchicine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Takeda
Pharmacokinetics, Healthy
Drug-Drug Interaction Study Between Colchicine and Cyclosporine
Colchicine is a substrate for both cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp). Cyclosporine is a potent inhibitor of both CYP3A4 and P-gp.
- Trial name
- NCT00983931
- Testing
- Colchicine, Cyclosporine
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Pharmacokinetics
Drug-Drug Interaction Study of Colchicine and Clarithromycin
Clarithromycin is a potent inhibitor of the activity of cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp). CYP 3A4 plays a role in the metabolism of colchicine and P-gp is responsible for the efflux of colchicine across…
- Trial name
- NCT00984061
- Testing
- colchicine, clarithromycin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Transcatheter Aortic Valve Replacement, Atrial Fibrillation New Onset
Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
Transcatheter aortic valve implantation (TAVI) is a well-established alternative to surgical aortic valve replacement for the treatment of patients with symptomatic severe aortic stenosis.
- Conditions
- Transcatheter Aortic Valve Replacement, Atrial Fibrillation New Onset, Pacemaker, Colchicine
- Trial name
- Co-STAR (NCT04870424)
- Testing
- Colchicine
- Where
- Switzerland
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Familial Mediterranean Fever
Pharmacokinetics Study of Colchicine in Familial Mediterranean Fever (FMF) Patients
Colchicine is widely recognized as safe and effective treatment of Familial Mediterranean Fever (FMF) in children and adults. Colchicine is currently used to treat FMF in younger patients by inexact dosing through breaking or…
- Trial name
- NCT01075906
- Testing
- colchicine sprinkle capsules
- Where
- 10 sites in United States, Armenia and 2 more
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Pharmacokinetics
A Pharmacokinetic Study of Colchicine With an Oral Contraceptive
This study will evaluate the effect, if any, of twice daily dosing of colchicine 0.6 mg at steady state on the steady state pharmacokinetic profile of ethinyl estradiol and norethindrone (Ortho-Novum 1/35).
- Trial name
- NCT01040845
- Testing
- Norethindrone/Ethinyl Estradiol, Colchicine
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mutual Pharmaceutical Company, Inc.
Overweight and Obesity
The Effect of Colchicine on Food-related Effort-based Decision Making in Brain and Behaviour in Overweight and Obesity
The main objective of the FLAIR-i study is to study the causal role of inflammation in affecting effort-based decision making in brain and behaviour in overweight and obesity, by comparing the effect of the anti-inflammatory…
- Trial name
- FLAIR-i (NCT05785429)
- Testing
- Colchicine 0.5 MG
- Where
- Netherlands
- Volunteers
- 59 people, healthy volunteers welcome
- Sponsor
- Donders Centre for Cognitive Neuroimaging
Cardiovascular Diseases, Cardiovascular Complication
Colchicine in Patients at Cardiac Risk Undergoing Major Non-Cardiac Surgery
Perioperative myocardial injury and major adverse cardiovascular events (MACE) are common causes of morbidity and mortality in patients at increased cardiovascular risk undergoing non-cardiac surgery.
- Conditions
- Cardiovascular Diseases, Cardiovascular Complication, Perioperative Complication, Myocardial Injury
- Trial name
- COLCAT (NCT06279000)
- Testing
- Colchicine
- Where
- Switzerland
- Volunteers
- 880 people, healthy volunteers welcome
- Sponsor
- Cantonal Hospital of St. Gallen