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Adsorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled SPD557 in Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01786876
First received: February 6, 2013
Last updated: April 25, 2014
Last verified: April 2014
History of Changes
Results First Received: February 10, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Healthy
Intervention: Drug: Radiolabeled SPD557

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Radiolabelled SSP-002358 A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1

Participant Flow:   Overall Study
    Radiolabelled SSP-002358
STARTED   6 
COMPLETED   6 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Radiolabelled SSP-002358 A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1

Baseline Measures
   Radiolabelled SSP-002358 
Overall Participants Analyzed 
[Units: Participants]
 		 6 
Age 
[Units: Participants]
 		 
<=18 years   0 
Between 18 and 65 years   6 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 29.5  (2.07) 
Gender 
[Units: Participants]
 		 
Female   0 
Male   6 
Region of Enrollment 
[Units: Participants]
 		 
UNITED STATES   6 


  Outcome Measures
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1.  Primary:   Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) of Radiolabelled SSP-002358   [ Time Frame: Over 240 hours post-dose ]
  Show Outcome Measure 1

2.  Primary:   Maximum Plasma Concentration (Cmax) of Radiolabelled SSP-002358   [ Time Frame: Over 240 hours post-dose ]
  Show Outcome Measure 2

3.  Primary:   Time to Maximum Plasma Concentration (Tmax) of Radiolabelled SSP-002358   [ Time Frame: Over 240 hours post-dose ]
  Show Outcome Measure 3

4.  Primary:   Plasma Half-Life (T1/2) of Radiolabelled SSP-002358   [ Time Frame: Over 240 hours post-dose ]
  Show Outcome Measure 4

5.  Primary:   AUC 0→∞ Whole Blood Total Radioactivity of Radiolabelled SSP-002358   [ Time Frame: Over 240 hours post-dose ]
  Show Outcome Measure 5

6.  Primary:   Cmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358   [ Time Frame: Over 240 hours post-dose ]
  Show Outcome Measure 6

7.  Primary:   Tmax Whole Blood Total Radioactivity of Radiolabelled SSP-002358   [ Time Frame: Over 240 hours post-dose ]
  Show Outcome Measure 7

8.  Primary:   Half-Life Whole Blood Total Radioactivity of Radiolabelled SSP-002358   [ Time Frame: Over 240 hours post-dose ]
  Show Outcome Measure 8

9.  Primary:   AUC 0→∞ Plasma Total Radioactivity of Radiolabelled SSP-002358   [ Time Frame: Over 240 hours post-dose ]
  Show Outcome Measure 9

10.  Primary:   Cmax Plasma Total Radioactivity of Radiolabelled SSP-002358   [ Time Frame: Over 240 hours post-dose ]
  Show Outcome Measure 10

11.  Primary:   Tmax Plasma Total Radioactivity of Radiolabelled SSP-002358   [ Time Frame: Over 240 hours post-dose ]
  Show Outcome Measure 11

12.  Primary:   Half-Life Plasma Total Radioactivity of Radiolabelled SSP-002358   [ Time Frame: Over 240 hours post-dose ]
  Show Outcome Measure 12

13.  Primary:   Percent Total Radioactivity Excreted in Urine of Radiolabelled SSP-002358   [ Time Frame: Over 240 hours post-dose ]
  Show Outcome Measure 13

14.  Primary:   Percent Total Radioactivity Excreted in Stool of Radiolabelled SSP-002358   [ Time Frame: Over 240 hours post-dose ]
  Show Outcome Measure 14


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Physician
Organization: Shire Development LLC
phone: +1 866 842 5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01786876     History of Changes
Other Study ID Numbers: SPD557-107
Study First Received: February 6, 2013
Results First Received: February 10, 2014
Last Updated: April 25, 2014