A Pilot Study for Pharmacokinetic Parameter of Colchicine in Patient Taking Rifampin

The purpose of this study is to examine the colchicine concentration before and after the administration of rifampicin.

Study Overview

• Status: Completed
• Conditions: Tuberculosis; Chronic Kidney Disease
• Intervention / Treatment: Drug: Rifampicin

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• from 18yrs to 80yrs , man and women
• the patient who are taking rifampicine over 2weeks
• the patient sign on the concent form

Exclusion Criteria:

• the patient have experience to take medication that have an effect on renal function
• the patient have hypersensitivity to colchicine
• At least, the average level of two separate blood pressure ( 2min interval ) shows that SBP <= 100 mmHg or >=160 mmHg and DBP <=60 mmHg >=100 mmHg, or Heart rate < 40 beats/min or > 90 beats/min
• uncontrolled hypertension
• serum albumin < 3.5, > 5 g/dL
• acute hepatitis or the level of AST or ALT is over 2times of normal range or the level of bilirubin is over 2.0 mg/dL
• the patient who have gastro-intestinal disease ( ex, crohn's disease, acute or chronic pancreatitis, ulcer )or who have the surgical history of gastrointestine.
• the patient who should take azathioprine, mercaptopurine, cyclophosphamide, Losartan, benzbromarone,fenofibrate,furosemide ,probenecid
• the patient who had taken part in the other study within 3months
• the patient who had gotten blood transfusion
• pregnant, breast feeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Rifampicin; experimentally check a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after taking Rifampicin	Drug: Rifampicin; single arm : check a change of Colchicine concentrations from basline at 1,2,4,8,24 hours after Rifampicin administration; Other Names: Rifampin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
a change of the colchicine concentration from baseline at 1,2,4,8,24 hours after Rifampicin administration	the colchicine concentration of baseline(C0) and at 1(C1),2(C2),4(C4),8(C8),24(C24) hours after Rifampicin administration

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): December 1, 2011
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: December 7, 2011
• First Submitted That Met QC Criteria: August 26, 2013
• First Posted (ESTIMATE): August 30, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 30, 2013
• Last Update Submitted That Met QC Criteria: August 26, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Urologic Diseases; Renal Insufficiency; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Actinomycetales Infections; Mycobacterium Infections; Kidney Diseases; Renal Insufficiency, Chronic; Tuberculosis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin
• Other Study ID Numbers: Colchicine_RFP 2011_1