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Phase I study to evaluate the excretion of radioactivity, the metabolic profile, pharmacokinetics, safety and tolerability following a single oral administration of [14C] SPD557 in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly SPD557 or its break down products are excreted by analysing blood, faeces and urine samples collected during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiolabeled SPD557 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiolabeled SPD557 | Drug | A single oral dose of 2 mg radiolabeled SPD557 administered 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-002358 | Area under the plasma concentration versus time curve from time 0 to infinity. 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. | Over 240 hours post-dose |
| Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358 | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered. | Over 240 hours post-dose |
| Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358 | Over 240 hours post-dose | |
| Plasma Half-Life (T1/2) of Radiolabelled SSP-002358 | Over 240 hours post-dose | |
| AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358 | Over 240 hours post-dose | |
| Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358 | Over 240 hours post-dose | |
| Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358 | Over 240 hours post-dose | |
| Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358 | Over 240 hours post-dose | |
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Key Inclusion Criteria:
Key Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance | Madison | Wisconsin | 53704 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27729771 | Result | Flach S, Croft M, Ding J, Budhram R, Pankratz T, Pennick M, Scarfe G, Troy S, Getsy J. Pharmacokinetics, absorption, and excretion of radiolabeled revexepride: a Phase I clinical trial using a microtracer and accelerator mass spectrometry-based approach. Drug Des Devel Ther. 2016 Sep 27;10:3125-3132. doi: 10.2147/DDDT.S107843. eCollection 2016. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiolabelled SSP-002358 | A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiolabelled SSP-002358 | A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1 |
| 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 | Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358 | Area under the plasma concentration versus time curve from time 0 to infinity. 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. | Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results. | Posted | Mean | Standard Deviation | pg*h/ml | Over 240 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 | Radiolabelled SSP-002358 | A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1 |
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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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| AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358 |
| Over 240 hours post-dose |
| Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358 | Over 240 hours post-dose |
| Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358 | Over 240 hours post-dose |
| Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358 | Over 240 hours post-dose |
| Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358 | Over 240 hours post-dose |
| Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358 | Over 240 hours post-dose |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358 | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administered. | Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results. | Posted | Mean | Standard Deviation | pg/ml | Over 240 hours post-dose |
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| Primary | Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358 | Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results. | Posted | Median | Full Range | hours | Over 240 hours post-dose |
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| Primary | Plasma Half-Life (T1/2) of Radiolabelled SSP-002358 | Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results. | Posted | Mean | Standard Deviation | hours | Over 240 hours post-dose |
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| Primary | AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358 | Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results. | Posted | Mean | Standard Deviation | pg equivalents*h/ml | Over 240 hours post-dose |
|
|
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| Primary | Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358 | Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results. | Posted | Mean | Standard Deviation | pg equivalents/ml | Over 240 hours post-dose |
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| Primary | Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358 | Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results. | Posted | Median | Full Range | hours | Over 240 hours post-dose |
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| Primary | Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358 | Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results. | Posted | Mean | Standard Deviation | hours | Over 240 hours post-dose |
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| Primary | AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358 | Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results. | Posted | Mean | Standard Deviation | pg equivalents*h/ml | Over 240 hours post-dose |
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| Primary | Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358 | Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results. | Posted | Mean | Standard Deviation | pg equivalents/ml | Over 240 hours post-dose |
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| Primary | Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358 | Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results. | Posted | Median | Full Range | hours | Over 240 hours post-dose |
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| Primary | Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358 | Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results. | Posted | Mean | Standard Deviation | hours | Over 240 hours post-dose |
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| Primary | Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358 | Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results. | Posted | Mean | Standard Deviation | percentage of radioactivity | Over 240 hours post-dose |
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| Primary | Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358 | Pharmacokinetic (PK) Analysis Set included all subjects with at least 1 PK parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set. Pharmacokinetic Concentration Analysis Set included all subjects who took at least 1 dose of investigational product and underwent plasma PK sampling and had evaluable PK assay results. | Posted | Mean | Standard Deviation | percentage of radioactivity | Over 240 hours post-dose |
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| 0 |
| 6 |
| 6 |
| 6 |
| Scratch | Injury, poisoning and procedural complications |
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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.