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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colcrys™ - young subjects (18-30 yrs) | Experimental | One single dose of Colcrys™ 0.6mg taken by mouth on day 1 |
|
| Colcrys™ - elderly subjects (≥60 yrs) | Experimental | One single dose of Colcrys™ 0.6mg taken by mouth on day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colcrys™ (colchicine) | Drug | 0.6 mg taken by mouth on day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | 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™ | 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™ | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Darin B Brimhall, D.O. | Novum | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Colcrys™ (Colchicine) - Young Subjects (18-30 Years) | All young subjects (18-30 years) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours. |
| FG001 | Colcrys™ (Colchicine) - Elderly Subjects (>60 Years) | All elderly subjects (≥ 60 years)received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Colcrys™ - Young Subjects and Colcrys™ - Elderly Subjects | Colcrys™ (colchicine) - young subjects (18-30 years): All young subjects (18-30 years) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours. Colcrys™ (colchicine) - Elderly subjects (≥60 years): All elderly subjects (≥ 60 years)received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Plasma Concentration (Cmax) | The maximum or peak concentration that Colcrys™ (colchicine) reaches in the plasma. | Posted | Mean | Standard Deviation | ng/mL | 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 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Colcrys™ - Young Subjects (18-30 Years) | All subjects received a single dose of Colcrys™ (colchicine 1 x 0.6 mg) on Day 1 following an overnight fast. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| somnolence | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Mutual Pharmaceutical Company, Inc. | 215-697-1743 | clinicaltrials@urlmutual.com |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | Posted | Mean | Standard Deviation | ng*hr/mL | 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 |
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|
|
| Primary | 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. | Posted | Mean | Standard Deviation | ng*hr/mL | 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 |
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| 0 |
| 20 |
| 7 |
| 20 |
| EG001 | Colcrys™ - Elderly Subjects (>60 Years Old) | All subjects received a single dose of Colcrys™ (colchicine 1 x 0.6 mg) on Day 1 following an overnight fast. | 0 | 18 | 8 | 18 |
| Tinnitus | Ear and labyrinth disorders | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | Non-systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| Feeling hot | General disorders | Non-systematic Assessment |
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| Blood pressure decreased | Investigations | Non-systematic Assessment |
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| Blood pressure increased | Investigations | Non-systematic Assessment |
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| Heart rate increased | Investigations | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | Non-systematic Assessment |
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| Headache | Nervous system disorders | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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