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

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ClinicalTrials.gov Identifier: NCT00919867
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : August 2, 2010
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label)
Condition Healthy
Interventions Drug: SPD503
Drug: VYVANSE
Drug: SPD503 and VYVANSE
Enrollment 42
Recruitment Details  
Pre-assignment Details Study consists of 3 treatment periods performed in 6 dosing sequences: SPD503 (extended-release guanfacine HCl) single 4 mg dose, Vyvanse (lisdexamfatamine dimesylate ) single 50 mg dose, and SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered. There is a washout period between each treatment period.
Arm/Group Title SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse Vyvanse First, Then SPD503, Then SPD503 + Vyvanse Vyvanse First, Then SPD503 + Vyvanse, Then SPD503 SPD503 + Vyvanse First, Then SPD503, Then Vyvanse SPD503 + Vyvanse, Then Vyvanse, Then SPD503
Hide Arm/Group Description SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
Period Title: First Intervention
Started 7 7 7 7 7 7
Completed 7 7 6 7 7 6
Not Completed 0 0 1 0 0 1
Reason Not Completed
Withdrawal by Subject             0             0             1             0             0             0
Physician Decision             0             0             0             0             0             1
Period Title: Washout
Started 7 7 6 7 7 6
Completed 7 7 6 7 7 6
Not Completed 0 0 0 0 0 0
Period Title: Second Intervention
Started 7 7 6 7 7 6
Completed 7 7 6 7 7 6
Not Completed 0 0 0 0 0 0
Period Title: Washout
Started 7 7 6 7 7 6
Completed 7 7 6 7 7 6
Not Completed 0 0 0 0 0 0
Period Title: Third Intervention
Started 7 7 6 7 7 6
Completed 7 7 6 7 7 6
Not Completed 0 0 0 0 0 0
Arm/Group Title SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse Vyvanse First, Then SPD503, Then SPD503 + Vyvanse Vyvanse First, Then SPD503 + Vyvanse, Then SPD503 SPD503 + Vyvanse First, Then SPD503, Then Vyvanse SPD503 + Vyvanse, Then Vyvanse, Then SPD503 Total
Hide Arm/Group Description SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention Total of all reporting groups
Overall Number of Baseline Participants 7 7 7 7 7 7 42
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 7 participants 7 participants 7 participants 7 participants 42 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
7
 100.0%
7
 100.0%
7
 100.0%
7
 100.0%
7
 100.0%
7
 100.0%
42
 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 7 participants 7 participants 7 participants 7 participants 7 participants 7 participants 42 participants
30.9  (6.20) 28.7  (8.44) 34.6  (10.18) 26.0  (5.29) 31.9  (8.19) 31.1  (4.18) 30.5  (7.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 7 participants 7 participants 7 participants 7 participants 7 participants 42 participants
Female
1
  14.3%
1
  14.3%
2
  28.6%
2
  28.6%
2
  28.6%
1
  14.3%
9
  21.4%
Male
6
  85.7%
6
  85.7%
5
  71.4%
5
  71.4%
5
  71.4%
6
  85.7%
33
  78.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 7 participants 7 participants 7 participants 7 participants 7 participants 7 participants 42 participants
7 7 7 7 7 7 42
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-amphetamine. 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 + Vyvanse
Hide Arm/Group Description:
Single 4 mg dose of extended-release Guanfacine HCl
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
Overall Number of Participants Analyzed 40 41
Mean (Standard Deviation)
Unit of Measure: ng/ml
2.55  (1.03) 2.97  (0.98)
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 + Vyvanse
Hide Arm/Group Description:
Single 4 mg dose of extended-release Guanfacine HCl
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
Overall Number of Participants Analyzed 37 39
Mean (Standard Deviation)
Unit of Measure: ng*h/ml
104.9  (34.7) 112.8  (35.7)
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 + Vyvanse
Hide Arm/Group Description:
Single 4 mg dose of extended-release Guanfacine HCl
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
Overall Number of Participants Analyzed 40 41
Mean (Standard Deviation)
Unit of Measure: hours
8.6  (7.7) 7.9  (5.0)
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 + Vyvanse
Hide Arm/Group Description:
Single 4 mg dose of extended-release Guanfacine HCl
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
Overall Number of Participants Analyzed 37 39
Mean (Standard Deviation)
Unit of Measure: hours
23.5  (10.2) 21.4  (8.2)
5.Primary Outcome
Title Cmax of d-Amphetamine
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 Vyvanse Alone SPD503 + Vyvanse
Hide Arm/Group Description:
Single 50 mg dose
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: ng/ml
36.48  (7.13) 36.50  (6.00)
6.Primary Outcome
Title AUC of d-Amphetamine
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 Vyvanse Alone SPD503 + Vyvanse
Hide Arm/Group Description:
Single 50 mg dose
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: ng*h/ml
686.9  (159.8) 708.4  (137.8)
7.Primary Outcome
Title Tmax of d-Amphetamine
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 Vyvanse Alone SPD503 + Vyvanse
Hide Arm/Group Description:
Single 50 mg dose
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: hours
4.2  (1.1) 3.9  (1.1)
8.Primary Outcome
Title T 1/2 of d-Amphetamine
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 Vyvanse Alone SPD503 + Vyvanse
Hide Arm/Group Description:
Single 50 mg dose
SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
Overall Number of Participants Analyzed 41 41
Mean (Standard Deviation)
Unit of Measure: hours
11.2  (1.6) 11.2  (1.5)
Time Frame [Not Specified]
Adverse Event Reporting Description 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 Vyvanse Alone SPD503 + Vyvanse
Hide Arm/Group Description Single 4 mg dose of extended-release Guanfacine HCl Single 50 mg dose SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
All-Cause Mortality
SPD503 Alone Vyvanse Alone SPD503 + Vyvanse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
SPD503 Alone Vyvanse Alone SPD503 + Vyvanse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/40 (0.00%)   0/41 (0.00%)   0/41 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SPD503 Alone Vyvanse Alone SPD503 + Vyvanse
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/40 (22.50%)   6/41 (14.63%)   6/41 (14.63%) 
Nervous system disorders       
Dizziness  2/40 (5.00%)  3/41 (7.32%)  3/41 (7.32%) 
Dizziness Postural  4/40 (10.00%)  1/41 (2.44%)  0/41 (0.00%) 
Headache  3/40 (7.50%)  2/41 (4.88%)  3/41 (7.32%) 
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: Gerald Tremblay, M.D.
Organization: Shire Pharmaceutical
EMail: gtremblay@shire.com
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00919867     History of Changes
Other Study ID Numbers: SPD503-115
First Submitted: June 10, 2009
First Posted: June 12, 2009
Results First Submitted: July 1, 2010
Results First Posted: August 2, 2010
Last Update Posted: February 6, 2014