HealthyPhase 1NCT01001052
Relative Bioavailability of Colcrys™ 0.6 mg Tablets in Healthy Young and Elderly Volunteers Under Fasted Conditions
A Phase 1 study testing Colcrys™ (colchicine) in people with Healthy, run by Mutual Pharmaceutical Company, Inc..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Colcrys™ (colchicine)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Oct 2009
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- Colcrys™ (colchicine)
- Keywords
- Healthy, bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colcrys™ (colchicine)Drug
Also called COLCRYS™
0.6 mg taken by mouth on day 1
| Study group | Role | What they receive |
|---|---|---|
| Colcrys™ - young subjects (18-30 yrs) | Experimental | One single dose of Colcrys™ 0.6mg taken by mouth on day 1 Receives: Drug: Colcrys™ (colchicine) |
| Colcrys™ - elderly subjects (≥60 yrs) | Experimental | One single dose of Colcrys™ 0.6mg taken by mouth on day 1 Receives: Drug: Colcrys™ (colchicine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
The maximum or peak concentration that Colcrys™ (colchicine) reaches in the plasma.
Measured: 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™
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.
Measured: 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™
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Darin B Brimhall, D.O., Principal investigator, Novum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001052
- Sponsor's protocol ID
- MPC-004-09-1027
- Status last verified
- Sep 2010
- First submitted
- 22 Oct 2009
- Last updated
- 28 Sep 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relative Bioavailability of Colcrys™ (Colchicine, USP) 0.6 mg Tablets in Healthy Young and Elderly Volunteers Under Fasted Conditions
- ClinicalTrials.gov ID
- NCT01001052
- Acronym / sponsor ID
- MPC-004-09-1027
- Conditions
- Healthy
- Keywords
- Healthy, bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Mutual Pharmaceutical Company, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Posted 14 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colcrys™ - young subjects (18-30 yrs) | Experimental | Drug: Colcrys™ (colchicine)One single dose of Colcrys™ 0.6mg taken by mouth on day 1 |
| Colcrys™ - elderly subjects (≥60 yrs) | Experimental | Drug: Colcrys™ (colchicine)One single dose of Colcrys™ 0.6mg taken by mouth on day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colcrys™ (colchicine)Also: COLCRYS™0.6 mg taken by mouth on day 1 | Drug | Colcrys™ - elderly subjects (≥60 yrs), Colcrys™ - young subjects (18-30 yrs) |
Primary outcome
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Darin B Brimhall, D.O. principal investigator
Novum
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Colcrys™ (colchicine) in people with Healthy, run by Mutual Pharmaceutical Company, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2010.