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A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01905540
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
Interventions: Drug: SSP-004184AQ
Drug: SSP-004184SS

  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
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
AQ-SS-AQ2 SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
AQ-SS-SS2 SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
SS-AQ-AQ2 SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
SS-AQ-SS2 SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.

Participant Flow for 3 periods

 Period 1:   Period 1
    AQ-SS-AQ2   AQ-SS-SS2   SS-AQ-AQ2   SS-AQ-SS2
STARTED   7   7   7   7 
COMPLETED   7   7   7   7 
NOT COMPLETED   0   0   0   0 

Period 2:   Period 2
    AQ-SS-AQ2   AQ-SS-SS2   SS-AQ-AQ2   SS-AQ-SS2
STARTED   7   7   7   7 
COMPLETED   7   7   7   7 
NOT COMPLETED   0   0   0   0 

Period 3:   Period 3
    AQ-SS-AQ2   AQ-SS-SS2   SS-AQ-AQ2   SS-AQ-SS2
STARTED   7   7   7   7 
COMPLETED   6   7   6   6 
NOT COMPLETED   1   0   1   1 
Not specified                1                0                1                1 



  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.
Safety Set: All enrolled subjects who had taken at least 1 dose of investigational product and had at least 1 post-dose safety assessment (defined as treatment emergent adverse events [TEAEs], physical examination findings, clinical laboratory test results, vital sign measurements, and 12-lead ECG readings).

Reporting Groups
  Description
AQ-SS-AQ2 SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
AQ-SS-SS2 SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
SS-AQ-AQ2 SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
SS-AQ-SS2 SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
Total Total of all reporting groups

Baseline Measures
   AQ-SS-AQ2   AQ-SS-SS2   SS-AQ-AQ2   SS-AQ-SS2   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 7   7   7   7   28 
Age 
[Units: Years]
Mean (Standard Deviation) 		 43.7  (12.58)   44.4  (11.53)   41.3  (10.27)   42.7  (13.46)   43  (11.4) 
Age, Customized 
[Units: Participants]
 		         
>=65 years   1   0   0   0   1 
Between 18 and 65 years   6   7   7   7   27 
Gender 
[Units: Participants]
 		         
Female   2   2   1   2   7 
Male   5   5   6   5   21 
Region of Enrollment 
[Units: Participants]
 		         
UNITED STATES   7   7   7   7   28 


  Outcome Measures
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1.  Primary:   Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After One Dose   [ Time Frame: Over 120 hours post-dose ]
  Show Outcome Measure 1

2.  Primary:   Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After One Dose   [ Time Frame: Over 120 hours post-dose ]
  Show Outcome Measure 2

3.  Primary:   Maximum Plasma Concentration (Cmax) of SSP-004184 After One Dose   [ Time Frame: Over 120 hours post-dose ]
  Show Outcome Measure 3

4.  Secondary:   Area Under the Steady-state Plasma Concentration-time Curve (AUClast) of SSP-004184 After Two Doses   [ Time Frame: Over 120 hours post-dose ]
  Show Outcome Measure 4

5.  Secondary:   Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Infinity (AUCinf) of SSP-004184 After Two Doses   [ Time Frame: Over 120 hours post-dose ]
  Show Outcome Measure 5

6.  Secondary:   Maximum Plasma Concentration (Cmax) of SSP-004184 After Two Doses   [ Time Frame: Over 120 hours post-dose ]
  Show Outcome Measure 6


  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
phone: +1 866 842 5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01905540     History of Changes
Other Study ID Numbers: SPD602-111
Study First Received: July 18, 2013
Results First Received: December 16, 2014
Last Updated: December 16, 2014