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Bioavailability Study of SPD489 Administered With Two Different Means of Administration in Healthy Adult Volunteers

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ClinicalTrials.gov Identifier: NCT01890785
Recruitment Status : Completed
First Posted : July 2, 2013
Results First Posted : April 21, 2014
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Shire

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Healthy Volunteers
Intervention Drug: Lisdexamfetamine Dimesylate
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sequence 1 Sequence 2 Sequence 3 Sequence 4 Sequence 5 Sequence 6
Hide Arm/Group Description Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
Period Title: First Intervention
Started 5 5 5 5 5 5
Completed 5 5 5 5 5 5
Not Completed 0 0 0 0 0 0
Period Title: Second Intervention
Started 5 5 5 5 5 5
Completed 5 5 5 5 5 5
Not Completed 0 0 0 0 0 0
Period Title: Third Intervention
Started 5 5 5 5 5 5
Completed 5 4 5 5 5 5
Not Completed 0 1 0 0 0 0
Reason Not Completed
Withdrawal by Subject             0             1             0             0             0             0
Arm/Group Title Sequence 1 Sequence 2 Sequence 3 Sequence 4 Sequence 5 Sequence 6 Total
Hide Arm/Group Description Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention Total of all reporting groups
Overall Number of Baseline Participants 5 5 5 5 5 5 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 5 participants 5 participants 5 participants 5 participants 30 participants
32.6  (10.16) 35.4  (12.42) 42.2  (4.44) 34.2  (12.42) 39.6  (9.86) 41.8  (10.06) 37.6  (10.07)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Between 18 and 65 years, inclusive Number Analyzed 5 participants 5 participants 5 participants 5 participants 5 participants 5 participants 30 participants
5 5 5 5 5 5 30
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 5 participants 5 participants 5 participants 5 participants 30 participants
Female
1
  20.0%
2
  40.0%
1
  20.0%
0
   0.0%
2
  40.0%
2
  40.0%
8
  26.7%
Male
4
  80.0%
3
  60.0%
4
  80.0%
5
 100.0%
3
  60.0%
3
  60.0%
22
  73.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
UNITED STATES Number Analyzed 5 participants 5 participants 5 participants 5 participants 5 participants 5 participants 30 participants
5 5 5 5 5 5 30
1.Primary Outcome
Title Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate
Hide Description AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Time Frame Up to 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Lisdexamfetamine Dimesylate Mixed in Orange Juice Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt Lisdexamfetamine Dimesylate Intact Capsule Fasting
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: ng*hr/ml
27.0  (7.8) 36.0  (14.2) 38.3  (12.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate Mixed in Orange Juice, Lisdexamfetamine Dimesylate Intact Capsule Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric least squares means
Estimated Value 0.708
Confidence Interval (2-Sided) 90%
0.655 to 0.766
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt, Lisdexamfetamine Dimesylate Intact Capsule Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric least squares means
Estimated Value 0.918
Confidence Interval (2-Sided) 90%
0.849 to 0.992
Estimation Comments [Not Specified]
2.Primary Outcome
Title Maximum Plasma Concentration (Cmax) for Lisdexamfetamine Dimesylate
Hide Description Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
Time Frame Up to 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Lisdexamfetamine Dimesylate Mixed in Orange Juice Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt Lisdexamfetamine Dimesylate Intact Capsule Fasting
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: ng/ml
24.5  (7.48) 32.2  (11.46) 38.5  (13.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate Mixed in Orange Juice, Lisdexamfetamine Dimesylate Intact Capsule Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric least squares means
Estimated Value 0.641
Confidence Interval (2-Sided) 90%
0.582 to 0.707
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt, Lisdexamfetamine Dimesylate Intact Capsule Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric least squares means
Estimated Value 0.828
Confidence Interval (2-Sided) 90%
0.752 to 0.912
Estimation Comments [Not Specified]
3.Primary Outcome
Title AUC for D-amphetamine
Hide Description d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.
Time Frame Up to 96 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Lisdexamfetamine Dimesylate Mixed in Orange Juice Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt Lisdexamfetamine Dimesylate Intact Capsule Fasting
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: ng*h/ml
1140.9  (274.1) 1110.1  (252.9) 1180.2  (295.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate Mixed in Orange Juice, Lisdexamfetamine Dimesylate Intact Capsule Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric least squares means
Estimated Value 0.970
Confidence Interval (2-Sided) 90%
0.937 to 1.004
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt, Lisdexamfetamine Dimesylate Intact Capsule Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric least squares means
Estimated Value 0.944
Confidence Interval (2-Sided) 90%
0.912 to 0.977
Estimation Comments [Not Specified]
4.Primary Outcome
Title Cmax for D-amphetamine
Hide Description d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.
Time Frame Up to 96 hours-post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
Arm/Group Title Lisdexamfetamine Dimesylate Mixed in Orange Juice Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt Lisdexamfetamine Dimesylate Intact Capsule Fasting
Hide Arm/Group Description:
Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
Overall Number of Participants Analyzed 30 30 30
Mean (Standard Deviation)
Unit of Measure: ng/ml
59.1  (9.47) 59.0  (9.28) 61.0  (10.81)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate Mixed in Orange Juice, Lisdexamfetamine Dimesylate Intact Capsule Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric least squares means
Estimated Value 0.971
Confidence Interval (2-Sided) 90%
0.945 to 0.998
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt, Lisdexamfetamine Dimesylate Intact Capsule Fasting
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Ratio of geometric least squares means
Estimated Value 0.970
Confidence Interval (2-Sided) 90%
0.944 to 0.997
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lisdexamfetamine Dimesylate Mixed in Orange Juice Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt Lisdexamfetamine Dimesylate Intact Capsule Fasting
Hide Arm/Group Description Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1) Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt(Single dose of a 70 mg capsule on Day 1) Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
All-Cause Mortality
Lisdexamfetamine Dimesylate Mixed in Orange Juice Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt Lisdexamfetamine Dimesylate Intact Capsule Fasting
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lisdexamfetamine Dimesylate Mixed in Orange Juice Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt Lisdexamfetamine Dimesylate Intact Capsule Fasting
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/30 (0.00%)      0/30 (0.00%)      0/30 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lisdexamfetamine Dimesylate Mixed in Orange Juice Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt Lisdexamfetamine Dimesylate Intact Capsule Fasting
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   16/30 (53.33%)      17/30 (56.67%)      9/30 (30.00%)    
Gastrointestinal disorders       
Dry mouth  3/30 (10.00%)  3 5/30 (16.67%)  5 3/30 (10.00%)  3
Metabolism and nutrition disorders       
Decreased appetite  9/30 (30.00%)  9 8/30 (26.67%)  8 3/30 (10.00%)  3
Nervous system disorders       
Dizziness  1/30 (3.33%)  1 2/30 (6.67%)  2 1/30 (3.33%)  1
Headache  4/30 (13.33%)  4 3/30 (10.00%)  3 4/30 (13.33%)  4
Psychomotor hyperactivity  1/30 (3.33%)  1 2/30 (6.67%)  2 1/30 (3.33%)  1
Psychiatric disorders       
Anxiety  0/30 (0.00%)  0 0/30 (0.00%)  0 2/30 (6.67%)  2
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 Physician
Organization: Shire Development LLC
Phone: +1 866 842 5335
Layout table for additonal information
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01890785     History of Changes
Other Study ID Numbers: SPD489-123
First Submitted: June 27, 2013
First Posted: July 2, 2013
Results First Submitted: March 14, 2014
Results First Posted: April 21, 2014
Last Update Posted: January 8, 2019