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

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ClinicalTrials.gov Identifier: NCT00901576
Recruitment Status : Completed
First Posted : May 14, 2009
Results First Posted : May 19, 2010
Last Update Posted : June 14, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Healthy
Interventions Drug: SPD503
Drug: Concerta
Drug: SPD503 + Concerta
Enrollment 38
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title 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
Hide Arm/Group Description 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 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 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 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 (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 (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
Period Title: First Intervention
Started 6 7 7 6 6 6
Completed 6 7 7 6 6 6
Not Completed 0 0 0 0 0 0
Period Title: Washout
Started 6 7 7 6 6 6
Completed 6 7 7 6 6 6
Not Completed 0 0 0 0 0 0
Period Title: Second Intervention
Started 6 7 7 6 6 6
Completed 5 7 7 5 6 5
Not Completed 1 0 0 1 0 1
Reason Not Completed
Withdrawal by Subject             0             0             0             1             0             1
Physician Decision             1             0             0             0             0             0
Period Title: Washout
Started 5 7 7 5 6 5
Completed 5 7 7 5 6 5
Not Completed 0 0 0 0 0 0
Period Title: Third Intervention
Started 5 7 7 5 6 5
Completed 5 7 7 5 6 5
Not Completed 0 0 0 0 0 0
Arm/Group Title 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
Hide Arm/Group Description 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 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 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 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 (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 (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 of all reporting groups
Overall Number of Baseline Participants 6 7 7 6 6 6 38
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 7 participants 6 participants 6 participants 6 participants 38 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
7
 100.0%
7
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
38
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 7 participants 7 participants 6 participants 6 participants 6 participants 38 participants
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)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 7 participants 7 participants 6 participants 6 participants 6 participants 38 participants
Female
1
  16.7%
1
  14.3%
3
  42.9%
1
  16.7%
1
  16.7%
2
  33.3%
9
  23.7%
Male
5
  83.3%
6
  85.7%
4
  57.1%
5
  83.3%
5
  83.3%
4
  66.7%
29
  76.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 6 participants 7 participants 7 participants 6 participants 6 participants 6 participants 38 participants
6
 100.0%
7
 100.0%
7
 100.0%
6
 100.0%
6
 100.0%
6
 100.0%
38
 100.0%
1.Primary Outcome
Title Maximum Plasma Concentration (Cmax) of Guanfacine
Hide Description [Not Specified]
Time Frame 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Population (PKP) consists of all subjects in the Safety Population who had evaluable concentration-time profiles for guanfacine or d-methylphenidate. The Safety Population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
Arm/Group Title SPD503 Alone SPD503 + Concerta
Hide Arm/Group Description:
Single 4 mg dose of extended-release Guanfacine HCl
SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
Overall Number of Participants Analyzed 37 36
Mean (Standard Deviation)
Unit of Measure: ng/ml
2.6  (0.9) 2.7  (0.9)
2.Primary Outcome
Title Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine
Hide Description [Not Specified]
Time Frame 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKP
Arm/Group Title SPD503 Alone SPD503 + Concerta
Hide Arm/Group Description:
Single 4 mg dose of extended-release Guanfacine HCl
SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
Overall Number of Participants Analyzed 33 34
Mean (Standard Deviation)
Unit of Measure: ng*h/ml
96.5  (37.3) 106.7  (39.9)
3.Primary Outcome
Title Time of Maximum Plasma Concentration (Tmax) of Guanfacine
Hide Description [Not Specified]
Time Frame 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKP
Arm/Group Title SPD503 Alone SPD503 + Concerta
Hide Arm/Group Description:
Single 4 mg dose of extended-release Guanfacine HCl
SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
Overall Number of Participants Analyzed 37 36
Mean (Standard Deviation)
Unit of Measure: hours
8.1  (8.1) 8.7  (6.3)
4.Primary Outcome
Title Time of Plasma Half-Life(T 1/2) of Guanfacine
Hide Description [Not Specified]
Time Frame 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKP
Arm/Group Title SPD503 Alone SPD503 + Concerta
Hide Arm/Group Description:
Single 4 mg dose of extended-release Guanfacine HCl
SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
Overall Number of Participants Analyzed 33 34
Mean (Standard Deviation)
Unit of Measure: hours
20.4  (7.9) 22.7  (10.6)
5.Primary Outcome
Title Cmax of d-Methylphenidate
Hide Description [Not Specified]
Time Frame 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKP
Arm/Group Title Concerta Alone SPD503 + Concerta
Hide Arm/Group Description:
Single 36 mg dose of extended-release Methylphenidate HCl
SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
Overall Number of Participants Analyzed 38 37
Mean (Standard Deviation)
Unit of Measure: ng/ml
9.9  (2.8) 9.5  (2.9)
6.Primary Outcome
Title AUC of d-Methylphenidate
Hide Description [Not Specified]
Time Frame 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKP
Arm/Group Title Concerta Alone SPD503 + Concerta
Hide Arm/Group Description:
Single 36 mg dose of extended-release Methylphenidate HCl
SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: ng*h/ml
102.8  (34.6) 100.5  (33.0)
7.Primary Outcome
Title Tmax of d-Methylphenidate
Hide Description [Not Specified]
Time Frame 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKP
Arm/Group Title Concerta Alone SPD503 + Concerta
Hide Arm/Group Description:
Single 36 mg dose of extended-release Methylphenidate HCl
SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
Overall Number of Participants Analyzed 38 37
Mean (Standard Deviation)
Unit of Measure: hours
6.9  (1.0) 7.4  (1.3)
8.Primary Outcome
Title T 1/2 of d-Methylphenidate
Hide Description [Not Specified]
Time Frame 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
PKP
Arm/Group Title Concerta Alone SPD503 + Concerta
Hide Arm/Group Description:
Single 36 mg dose of extended-release Methylphenidate HCl
SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
Overall Number of Participants Analyzed 32 32
Mean (Standard Deviation)
Unit of Measure: hours
3.9  (0.7) 4.1  (0.6)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety Population (SP) consisted of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment
 
Arm/Group Title SPD503 Alone Concerta Alone SPD503 + Concerta
Hide Arm/Group Description Single 4 mg dose of extended-release guanfacine HCl Single 36 mg dose of extended-release methylphenidate HCl SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
All-Cause Mortality
SPD503 Alone Concerta Alone SPD503 + Concerta
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
SPD503 Alone Concerta Alone SPD503 + Concerta
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/37 (2.70%)   0/38 (0.00%)   0/37 (0.00%) 
Nervous system disorders       
Orthostatic syncope  1/37 (2.70%)  0/38 (0.00%)  0/37 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SPD503 Alone Concerta Alone SPD503 + Concerta
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   6/37 (16.22%)   8/38 (21.05%)   4/37 (10.81%) 
Gastrointestinal disorders       
Vomiting  0/37 (0.00%)  2/38 (5.26%)  0/37 (0.00%) 
Nervous system disorders       
Dizziness  1/37 (2.70%)  2/38 (5.26%)  1/37 (2.70%) 
Dizziness postural  3/37 (8.11%)  0/38 (0.00%)  0/37 (0.00%) 
Headache  2/37 (5.41%)  4/38 (10.53%)  3/37 (8.11%) 
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.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Shire
Phone: +1 866 842 5335
EMail: ClinicalTransparency@shire.com
Layout table for additonal information
Responsible Party: Takeda ( Shire )
ClinicalTrials.gov Identifier: NCT00901576    
Other Study ID Numbers: SPD503-114
First Submitted: May 12, 2009
First Posted: May 14, 2009
Results First Submitted: April 16, 2010
Results First Posted: May 19, 2010
Last Update Posted: June 14, 2021