This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

The Effect of Food on the Bioavailability of a Single Dose of SSP-004184SS in Healthy Adult Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01905553
First received: July 18, 2013
Last updated: December 16, 2014
Last verified: December 2014
History of Changes
Results First Received: December 16, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Healthy
Intervention: Drug: SSP-004184SS

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
SSP-004184SS Fed First Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions.
SSP-004184SS Fasted First Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.

Participant Flow for 2 periods

 Period 1:   Period 1
    SSP-004184SS Fed First   SSP-004184SS Fasted First
STARTED   5   4 
COMPLETED   5   4 
NOT COMPLETED   0   0 

Period 2:   Period 2
    SSP-004184SS Fed First   SSP-004184SS Fasted First
STARTED   5   4 
COMPLETED   4   4 
NOT COMPLETED   1   0 
Adverse Event                1                0 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
The Safety Set consists of all subjects who have taken at least 1 dose of investigational product and have at least 1 post-dose safety assessment.

Reporting Groups
  Description
SSP-004184SS Fed First Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions.
SSP-004184SS Fasted First Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.
Total Total of all reporting groups

Baseline Measures
   SSP-004184SS Fed First   SSP-004184SS Fasted First   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 5   4   9 
Age 
[Units: Participants]
 		     
<=18 years   0   0   0 
Between 18 and 65 years   5   4   9 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 42  (10.89)   35  (7.62)   38.9  (9.73) 
Gender 
[Units: Participants]
 		     
Female   1   2   3 
Male   4   2   6 
Region of Enrollment 
[Units: Participants]
 		     
UNITED STATES   5   4   9 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 Under Fasted and Fed Conditions   [ Time Frame: Over 96 Hours post-dose ]
  Show Outcome Measure 1

2.  Primary:   Area Under the Concentration-time Curve From Time Zero to the Time of the Last Measureable Concentration (AUClast) of SSP-004184 Under Fed and Fasted Conditions   [ Time Frame: Over 96 hours post-dose ]
  Show Outcome Measure 2

3.  Primary:   Maximum Plasma Concentration (Cmax) of SSP-004184 Under Fed and Fasted Conditions   [ Time Frame: Over 96 hours post-dose ]
  Show Outcome Measure 3


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  More Information
  Hide More Information

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
phone: +1 866 842 5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01905553     History of Changes
Other Study ID Numbers: SPD602-113
Study First Received: July 18, 2013
Results First Received: December 16, 2014
Last Updated: December 16, 2014