- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01001052
Relative Bioavailability of Colcrys™ 0.6 mg Tablets in Healthy Young and Elderly Volunteers Under Fasted Conditions
September 24, 2010 updated by: Mutual Pharmaceutical Company, Inc.
Relative Bioavailability of Colcrys™ (Colchicine, USP) 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 older, generally healthy subjects 60 years of age or older following an overnight fast.
Study Overview
Detailed Description
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 older, generally healthy subjects 60 years of age or older following an overnight fast.
On study Day 1 following an overnight fast, twenty healthy, non-smoking, non-obese male and female subjects between the ages of 18 and 30 and twenty generally healthy, non-smoking, non-obese male and female subjects over 60 years of age will be administered one single dose of Colcrys™ (1 x 0.6 mg tablet).
Fasting will continue for 4 hours after the dose.
Blood samples will be drawn from all participants before dosing and for 24 hours post-dose on a confined basis at times sufficient to adequately define the pharmacokinetics of Colcrys.
Blood sampling will continue on a non-confined basis at 36, 48, 60 and 72 hours post-dose.
Subjects will be monitored throughout participation in the study for adverse reactions to the study drug and/or procedures.
Vitals signs (temperature, respiratory rate, pulse rate and blood pressure) will be measured in the sitting position prior to dosing.
Seated blood pressure and pulse will be measured at approximately 1, 3, 6 and 12 hours after dosing and prior to release from the facility.
All adverse events whether elicited by query, spontaneously reported, or observed by clinic staff will be evaluated by the Investigator and reported in the subject's case report form.
Study Type
Interventional
Enrollment (Actual)
38
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy adults 18-30 years of age or generally healthy adults over 60 years of age (elderly subjects with minor renal impairment may be allowed to participate at the discretion of the investigator), non-smoking and non-pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index (BMI) of 18-30 kg/m2.
Exclusion Criteria:
- Recent participation (within 30 days) in other research studies
- Recent significant blood donation or plasma donation
- Pregnant or lactating
- Test positive at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV)
- History of treatment for drug or alcohol addiction within the previous 12 months or excessive alcohol consumption during the past 12 months
- Significant history of chronic infectious disease, system disorders, organ dysfunction, especially cardiovascular disorders (angina, heart failure, irregular heartbeats, heart attack, hypertension, hypotension) stroke, renal or hepatic disorder, diabetes or bleeding disorders, gastrointestinal disease or psychiatric disorders.
- Presence of a medical condition requiring regular treatment with prescription drugs
- Subjects who have used any drugs or substances known to inhibit or induce drug-metabolizing enzymes within 30 days prior to the first dose and throughout the study
- Drug allergies or sensitivity to colchicine
- Positive test results for drugs of abuse at screening
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Colcrys™ - young subjects (18-30 yrs)
One single dose of Colcrys™ 0.6mg taken by mouth on day 1
|
0.6 mg taken by mouth on day 1
Other Names:
|
Experimental: Colcrys™ - elderly subjects (≥60 yrs)
One single dose of Colcrys™ 0.6mg taken by mouth on day 1
|
0.6 mg taken by mouth on day 1
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maximum Plasma Concentration (Cmax)
Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose
|
The maximum or peak concentration that Colcrys™ (colchicine) reaches in the plasma.
|
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose
|
Area Under the Concentration Versus Time Curve From Time 0 Extrapolated to Infinity [AUC(0-∞)] for Colcrys™
Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose
|
The area under the plasma concentration versus time curve from time 0 to infinity.
AUC(0-∞) was calculated as the sum of AUC(0-t) plus the ratio of the last measurable plasma concentration to the elimination rate constant.
|
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose
|
Area Under the Concentration Versus Time Curve From Time 0 to Time t [AUC(0-t)] for Colcrys™
Time Frame: serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose
|
The area under the plasma concentration versus time curve, from time 0 to the time of the last measurable concentration (t), as calculated by the linear trapezoidal rule.
|
serial pharmacokinetic plasma concentrations were drawn prior to dose administration (0 hour) and at 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 16, 18, 24, 36, 48, 60 and 72 hours post-dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Darin B Brimhall, D.O., NOVUM
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Actual)
October 1, 2009
Study Completion (Actual)
October 1, 2009
Study Registration Dates
First Submitted
October 22, 2009
First Submitted That Met QC Criteria
October 22, 2009
First Posted (Estimate)
October 23, 2009
Study Record Updates
Last Update Posted (Estimate)
September 28, 2010
Last Update Submitted That Met QC Criteria
September 24, 2010
Last Verified
September 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MPC-004-09-1027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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