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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] Prucalopride Succinate in healthy male volunteers aged 18 to 50 years (inclusive).The purpose of this study is to investigate how and how quickly Prucalopride Succinate 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 Prucalopride Succinate | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiolabeled Prucalopride Succinate | Drug | A single oral dose of 2 mg radiolabeled prucalopride succinate 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 Prucalopride Succinate | 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 Prucalopride Succinate | 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 Prucalopride Succinate | Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. | Over 240 hours post-dose |
| Plasma Half-Life (T1/2) of Radiolabelled Prucalopride Succinate | The time it takes for the blood plasma concentration of a substance to halve. | Over 240 hours post-dose |
| Total Body Clearance (CL/F) of Radiolabelled Prucalopride Succinate | The rate at which a drug is removed from the body. | Over 240 hours post-dose |
| Volume of Distribution (Vz/F) of Radiolabelled Prucalopride Succinate | The distribution of a medication between plasma and the rest of the body. | Over 240 hours post-dose |
| AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate |
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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 Global Clinical Research Unit Inc. | Madison | Wisconsin | 53704 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27614912 | Derived | Flach S, Scarfe G, Dragone J, Ding J, Seymour M, Pennick M, Pankratz T, Troy S, Getsy J. A Phase I Study to Investigate the Absorption, Pharmacokinetics, and Excretion of [(14)C]Prucalopride After a Single Oral Dose in Healthy Volunteers. Clin Ther. 2016 Sep;38(9):2106-15. doi: 10.1016/j.clinthera.2016.08.003. Epub 2016 Sep 7. |
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| ID | Title | Description |
|---|---|---|
| FG000 | [14C] PRUCALOPRIDE SUCCINATE | A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | [14C] PRUCALOPRIDE SUCCINATE |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Prucalopride Succinate | 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 included all subjects with at least 1 pharmacokinetic parameter estimated adequately in the Pharmacokinetic Concentration Analysis Set which included all subjects who took 1 dose of investigational product, underwent plasma pharmacokinetic sampling, and had evaluable pharmacokinetic assay results. | Posted | Mean | Standard Deviation | ng*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 | [14C] PRUCALOPRIDE SUCCINATE | A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal discomfort | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| Over 240 hours post-dose |
| Cmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate | Over 240 hours post-dose |
| Tmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate | Over 240 hours post-dose |
| Half-Life Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate | Over 240 hours post-dose |
| AUC 0→∞ Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate | Over 240 hours post-dose |
| Cmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate | Over 240 hours post-dose |
| Tmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate | Over 240 hours post-dose |
| Half-Life Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate | Over 240 hours post-dose |
| Percent Total Radioactivity Excreted in Urine of Radiolabelled Prucalopride Succinate | 240 hours post-dose |
| Percent Total Radioactivity Excreted in Stool of Radiolabelled Prucalopride Succinate | Over 240 hours post-dose |
| Years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Maximum Plasma Concentration (Cmax) of Radiolabelled Prucalopride Succinate | 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 Analysis Set | Posted | Mean | Standard Deviation | ng/ml | Over 240 hours post-dose |
|
|
|
| Primary | Time to Maximum Plasma Concentration (Tmax) of Radiolabelled Prucalopride Succinate | Tmax is the time after administration of a drug when the maximum plasma concentration in the body is reached. | Pharmacokinetic Analysis Set | Posted | Median | Full Range | hours | Over 240 hours post-dose |
|
|
|
| Primary | Plasma Half-Life (T1/2) of Radiolabelled Prucalopride Succinate | The time it takes for the blood plasma concentration of a substance to halve. | Pharmacokinetic Analysis Set | Posted | Mean | Standard Deviation | hours | Over 240 hours post-dose |
|
|
|
| Primary | Total Body Clearance (CL/F) of Radiolabelled Prucalopride Succinate | The rate at which a drug is removed from the body. | Pharmacokinetic Analysis Set | Posted | Mean | Standard Deviation | L/h | Over 240 hours post-dose |
|
|
|
| Primary | Volume of Distribution (Vz/F) of Radiolabelled Prucalopride Succinate | The distribution of a medication between plasma and the rest of the body. | Pharmacokinetic Analysis Set | Posted | Mean | Standard Deviation | Liters | Over 240 hours post-dose |
|
|
|
| Primary | AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate | Pharmacokinetic Analysis Set | Posted | Mean | Standard Deviation | ng equivalents*h/ml | Over 240 hours post-dose |
|
|
|
| Primary | Cmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate | Pharmacokinetic Analysis Set | Posted | Mean | Standard Deviation | ng equivalents/ml | Over 240 hours post-dose |
|
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| Primary | Tmax Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate | Pharmacokinetic Analysis Set | Posted | Median | Full Range | hours | Over 240 hours post-dose |
|
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| Primary | Half-Life Whole Blood Total Radioactivity of Radiolabelled Prucalopride Succinate | Pharmacokinetic Analysis Set | Posted | Mean | Standard Deviation | hours | Over 240 hours post-dose |
|
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| Primary | AUC 0→∞ Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate | Pharmacokinetic Analysis Set | Posted | Mean | Standard Deviation | ng equivalents*h/ml | Over 240 hours post-dose |
|
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|
| Primary | Cmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate | Pharmacokinetic Analysis Set | Posted | Mean | Standard Deviation | ng equivalents/ml | Over 240 hours post-dose |
|
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| Primary | Tmax Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate | Pharmacokinetic Analysis Set | Posted | Median | Full Range | hours | Over 240 hours post-dose |
|
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| Primary | Half-Life Plasma Total Radioactivity of Radiolabelled Prucalopride Succinate | Pharmacokinetic Analysis Set | Posted | Mean | Standard Deviation | hours | Over 240 hours post-dose |
|
|
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| Primary | Percent Total Radioactivity Excreted in Urine of Radiolabelled Prucalopride Succinate | Pharmacokinetic Analysis Set | Posted | Mean | Standard Deviation | percentage of radioactvity | 240 hours post-dose |
|
|
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| Primary | Percent Total Radioactivity Excreted in Stool of Radiolabelled Prucalopride Succinate | Pharmacokinetic Analysis Set | Posted | Mean | Standard Deviation | percentage of radioactivity | Over 240 hours post-dose |
|
|
|
| 0 |
| 6 |
| 4 |
| 6 |
| Diarrhoea | Gastrointestinal disorders |
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| Presyncope | Nervous system disorders |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders |
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| Dry skin | Skin and subcutaneous tissue disorders |
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| Photosensitivity reaction | Skin and subcutaneous tissue disorders |
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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.