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SSP-002358 Drug Interaction Study With Omeprazole

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01415349
First Posted: August 11, 2011
Last Update Posted: June 13, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
Results First Submitted: June 1, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Healthy
Interventions: Drug: SSP-002358
Drug: SSP-002358 + omeprazole

  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
SSP-002358 First A single dose of 1 mg SSP-002358 in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 2
SSP-002358 + Omeprazole First A single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 in treatment period 2

Participant Flow for 2 periods

Period 1:   Treatment Period 1
    SSP-002358 First   SSP-002358 + Omeprazole First
STARTED   21   21 
COMPLETED   21   19 
NOT COMPLETED   0   2 
Adverse Event                0                1 
Withdrawal by Subject                0                1 

Period 2:   Treatment Period 2
    SSP-002358 First   SSP-002358 + Omeprazole First
STARTED   21   19 
COMPLETED   21   19 
NOT COMPLETED   0   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.
No text entered.

Reporting Groups
  Description
Safety Analysis Set Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.

Baseline Measures
   Safety Analysis Set 
Overall Participants Analyzed 
[Units: Participants]
 42 
Age 
[Units: Years]
Mean (Standard Deviation)
 27.4  (10.52) 
Age, Customized 
[Units: Participants]
 
Between 18 and 55 years   42 
Gender 
[Units: Participants]
 
Female   23 
Male   19 
Region of Enrollment 
[Units: Participants]
 
Netherlands   42 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Plasma Concentration (Cmax) for SSP-002358   [ Time Frame: Assessed over 48 hours post-dose ]

2.  Primary:   Area Under the Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC 0→∞) for SSP-002358   [ Time Frame: Assessed over 48 hours post-dose ]


  Serious Adverse Events


  Other Adverse Events


  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 Pharmaceutical
phone: 1 866 842 5335



Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01415349     History of Changes
Other Study ID Numbers: SPD557-101
2011-001565-41 ( EudraCT Number )
First Submitted: August 10, 2011
First Posted: August 11, 2011
Results First Submitted: June 1, 2012
Results First Posted: July 6, 2012
Last Update Posted: June 13, 2014