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To evaluate how the body absorbs, metabolizes (breaks down) and excretes (eliminates) the study drug. Further, the study will determine how much of the study drug gets into the bloodstream and how long it takes the body to get rid of it when given as a single dose to healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiolabeled SPD602 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiolabeled SPD602 (FBS0701, SSP-004184) | Drug | A single oral dose of 3g of radio-labelled SSP-004184 on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-004184 | AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-004184 | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-004184 | Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| Plasma Half-Life (T1/2) of Radiolabelled SSP-004184 | The time it takes for the blood plasma concentration of a substance to halve. | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| Total Body Clearance (CL/F) of Radio-Labelled SSP-004184 | The rate at which a drug is removed from the body. | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
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Inclusion Criteria:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc | Madison | Wisconsin | 53704 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | [14C]SSP-004184 | A single oral dose of 3g of radio-labelled SSP-004184 on Day 1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | [14C]SSP-004184 | A single oral dose of 3g of radio-labelled SSP-004184 on Day 1 |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-004184 | AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. | The Pharmacokinetic Analysis Set (PAS) was defined as all subjects in the Safety Analysis Set (SAS) for whom the primary pharmacokinetic data are considered sufficient and interpretable. The SAS consisted of subjects who received at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | Posted | Mean | Standard Deviation | ng*hr/ml | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
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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 | [14C]SSP-004184 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| C572777 | 4,5-dihydro-2-(2-hydroxy-3-(3,6,9-trioxadecyloxy)phenyl)-4-methyl-4-thiazolecarboxylic acid |
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| Volume of Distribution (Vz/F) of Radiolabelled SSP-004184 | The distribution of a medication between plasma and the rest of the body. | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-004184 | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184 | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184 | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-004184 | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| CL/F Whole Blood Total Radioactivity of Radio-Labelled SSP-004184 | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| Vz/F Whole Blood Total Radioactivity of Radiolabelled SSP-004184 | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-004184 | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| Cmax Plasma Total Radioactivity of Radiolabelled SSP-004184 | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| Tmax Plasma Total Radioactivity of Radiolabelled SSP-004184 | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| Half-Life Plasma Total Radioactivity of Radiolabelled SSP-004184 | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| CL/F Plasma Total Radioactivity of Radio-Labelled SSP-004184 | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| Vz/F Plasma Total Radioactivity of Radiolabelled SSP-004184 | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-004184 | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-004184 | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-004184 | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. | PAS | Posted | Mean | Standard Deviation | ng/ml | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| Primary | Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-004184 | Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. | PAS | Posted | Median | Full Range | hours | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| Primary | Plasma Half-Life (T1/2) of Radiolabelled SSP-004184 | The time it takes for the blood plasma concentration of a substance to halve. | PAS | Posted | Mean | Standard Deviation | hours | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| Primary | Total Body Clearance (CL/F) of Radio-Labelled SSP-004184 | The rate at which a drug is removed from the body. | PAS | Posted | Mean | Standard Deviation | L/hr | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| Primary | Volume of Distribution (Vz/F) of Radiolabelled SSP-004184 | The distribution of a medication between plasma and the rest of the body. | PAS | Posted | Mean | Standard Deviation | Liters | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| Primary | AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-004184 | PAS | Posted | Mean | Standard Deviation | ng equivalents*hr/g | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| Primary | Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184 | PAS | Posted | Mean | Standard Deviation | ng equivalents/ml | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| Primary | Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-004184 | PAS | Posted | Median | Full Range | hours | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| Primary | Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-004184 | PAS | Posted | Mean | Standard Deviation | hours | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| Primary | CL/F Whole Blood Total Radioactivity of Radio-Labelled SSP-004184 | PAS | Posted | Mean | Standard Deviation | L/hr | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| Primary | Vz/F Whole Blood Total Radioactivity of Radiolabelled SSP-004184 | PAS | Posted | Mean | Standard Deviation | Liters | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| Primary | AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-004184 | PAS | Posted | Mean | Standard Deviation | ng equivalents*hr/ml | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| Primary | Cmax Plasma Total Radioactivity of Radiolabelled SSP-004184 | PAS | Posted | Mean | Standard Deviation | ng equivalents/ml | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| Primary | Tmax Plasma Total Radioactivity of Radiolabelled SSP-004184 | PAS | Posted | Median | Full Range | hours | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| Primary | Half-Life Plasma Total Radioactivity of Radiolabelled SSP-004184 | PAS | Posted | Mean | Standard Deviation | hours | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| Primary | CL/F Plasma Total Radioactivity of Radio-Labelled SSP-004184 | PAS | Posted | Mean | Standard Deviation | L/hr | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
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| Primary | Vz/F Plasma Total Radioactivity of Radiolabelled SSP-004184 | PAS | Posted | Mean | Standard Deviation | Liters | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
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| Primary | Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-004184 | PAS | Posted | Mean | Standard Deviation | percentage of radioactivity | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
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| Primary | Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-004184 | PAS | Posted | Mean | Standard Deviation | percentage of radioactivity | Within 30 minutes pre-dose, and Post-dose 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10 12, 16, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, & 288 hours. |
|
|
|
| 0 |
| 6 |
| 6 |
| 6 |
| Folliculitis | Infections and infestations |
|
| Chromaturia | Renal and urinary disorders |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.