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A Drug Interaction Study of SPD503 and Concerta Administered Alone and In Combination in Normal Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00901576
First received: May 12, 2009
Last updated: January 7, 2014
Last verified: January 2014
History of Changes
Results First Received: April 16, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Open Label
Condition: Healthy
Interventions: Drug: SPD503
Drug: Concerta
Drug: SPD503 + Concerta

  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
Study consists of 3 regimens: SPD503 (extended-release guanfacine HCl) single 4 mg dose, Concerta (extended-release methylphenidate HCl) single 36 mg dose, and SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered. Each dosing regimen is separated by a washout period and performed in 6 different dosing sequences.

Reporting Groups
  Description
SPD503 First, Then Concerta, Then SPD503 + Concerta SPD503 single 4 mg dose in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
SPD503 First, Then SPD503 + Concerta, Then Concerta SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, Concerta single 36 mg dose in third intervention
Concerta First, Then SPD503, Then SPD503 + Concerta Concerta single 36 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
Concerta First, Then SPD503 + Concerta, Then SPD503 Concerta single 36 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
SPD503 + Concerta First, Then SPD503, Then Concerta SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Concerta single 36 mg dose in third intervention
SPD503 + Concerta First, Then Concerta, Then SPD503 SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention

Participant Flow for 5 periods

 Period 1:   First Intervention
    SPD503 First, Then Concerta, Then SPD503 + Concerta   SPD503 First, Then SPD503 + Concerta, Then Concerta   Concerta First, Then SPD503, Then SPD503 + Concerta   Concerta First, Then SPD503 + Concerta, Then SPD503   SPD503 + Concerta First, Then SPD503, Then Concerta   SPD503 + Concerta First, Then Concerta, Then SPD503
STARTED   6   7   7   6   6   6 
COMPLETED   6   7   7   6   6   6 
NOT COMPLETED   0   0   0   0   0   0 

Period 2:   Washout
    SPD503 First, Then Concerta, Then SPD503 + Concerta   SPD503 First, Then SPD503 + Concerta, Then Concerta   Concerta First, Then SPD503, Then SPD503 + Concerta   Concerta First, Then SPD503 + Concerta, Then SPD503   SPD503 + Concerta First, Then SPD503, Then Concerta   SPD503 + Concerta First, Then Concerta, Then SPD503
STARTED   6   7   7   6   6   6 
COMPLETED   6   7   7   6   6   6 
NOT COMPLETED   0   0   0   0   0   0 

Period 3:   Second Intervention
    SPD503 First, Then Concerta, Then SPD503 + Concerta   SPD503 First, Then SPD503 + Concerta, Then Concerta   Concerta First, Then SPD503, Then SPD503 + Concerta   Concerta First, Then SPD503 + Concerta, Then SPD503   SPD503 + Concerta First, Then SPD503, Then Concerta   SPD503 + Concerta First, Then Concerta, Then SPD503
STARTED   6   7   7   6   6   6 
COMPLETED   5   7   7   5   6   5 
NOT COMPLETED   1   0   0   1   0   1 
Withdrawal by Subject                0                0                0                1                0                1 
Physician Decision                1                0                0                0                0                0 

Period 4:   Washout
    SPD503 First, Then Concerta, Then SPD503 + Concerta   SPD503 First, Then SPD503 + Concerta, Then Concerta   Concerta First, Then SPD503, Then SPD503 + Concerta   Concerta First, Then SPD503 + Concerta, Then SPD503   SPD503 + Concerta First, Then SPD503, Then Concerta   SPD503 + Concerta First, Then Concerta, Then SPD503
STARTED   5   7   7   5   6   5 
COMPLETED   5   7   7   5   6   5 
NOT COMPLETED   0   0   0   0   0   0 

Period 5:   Third Intervention
    SPD503 First, Then Concerta, Then SPD503 + Concerta   SPD503 First, Then SPD503 + Concerta, Then Concerta   Concerta First, Then SPD503, Then SPD503 + Concerta   Concerta First, Then SPD503 + Concerta, Then SPD503   SPD503 + Concerta First, Then SPD503, Then Concerta   SPD503 + Concerta First, Then Concerta, Then SPD503
STARTED   5   7   7   5   6   5 
COMPLETED   5   7   7   5   6   5 
NOT COMPLETED   0   0   0   0   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
SPD503 First, Then Concerta, Then SPD503 + Concerta SPD503 single 4 mg dose in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
SPD503 First, Then SPD503 + Concerta, Then Concerta SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, Concerta single 36 mg dose in third intervention
Concerta First, Then SPD503, Then SPD503 + Concerta Concerta single 36 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
Concerta First, Then SPD503 + Concerta, Then SPD503 Concerta single 36 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
SPD503 + Concerta First, Then SPD503, Then Concerta SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Concerta single 36 mg dose in third intervention
SPD503 + Concerta First, Then Concerta, Then SPD503 SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
Total Total of all reporting groups

Baseline Measures
   SPD503 First, Then Concerta, Then SPD503 + Concerta   SPD503 First, Then SPD503 + Concerta, Then Concerta   Concerta First, Then SPD503, Then SPD503 + Concerta   Concerta First, Then SPD503 + Concerta, Then SPD503   SPD503 + Concerta First, Then SPD503, Then Concerta   SPD503 + Concerta First, Then Concerta, Then SPD503   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 6   7   7   6   6   6   38 
Age 
[Units: Participants]
 		             
<=18 years   0   0   0   0   0   0   0 
Between 18 and 65 years   6   7   7   6   6   6   38 
>=65 years   0   0   0   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 27.7  (5.54)   32.6  (6.70)   32.1  (8.01)   31.5  (8.41)   29.8  (2.64)   30.3  (5.68)   30.8  (6.28) 
Gender 
[Units: Participants]
 		             
Female   1   1   3   1   1   2   9 
Male   5   6   4   5   5   4   29 
Region of Enrollment 
[Units: Participants]
 		             
United States   6   7   7   6   6   6   38 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Plasma Concentration (Cmax) of Guanfacine   [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose ]
  Show Outcome Measure 1

2.  Primary:   Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine   [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose ]
  Show Outcome Measure 2

3.  Primary:   Time of Maximum Plasma Concentration (Tmax) of Guanfacine   [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose ]
  Show Outcome Measure 3

4.  Primary:   Time of Plasma Half-Life(T 1/2) of Guanfacine   [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose ]
  Show Outcome Measure 4

5.  Primary:   Cmax of d-Methylphenidate   [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose ]
  Show Outcome Measure 5

6.  Primary:   AUC of d-Methylphenidate   [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose ]
  Show Outcome Measure 6

7.  Primary:   Tmax of d-Methylphenidate   [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose ]
  Show Outcome Measure 7

8.  Primary:   T 1/2 of d-Methylphenidate   [ Time Frame: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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  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: Gerald Tremblay, MD
Organization: Shire Pharmaceutical
e-mail: gtremblay@shire.com


Publications of Results:


Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00901576     History of Changes
Other Study ID Numbers: SPD503-114
Study First Received: May 12, 2009
Results First Received: April 16, 2010
Last Updated: January 7, 2014