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

• Sponsor: Shire (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01890785
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Actual Duration (Months): 1.2
• Patients Per Site Per Month: 24

Study Details

Study Description

Brief Summary

Compare the pharmacokinetic profiles when the contents are emptied into a soft food and orange juice compared to the SPD489 when swallowed as an intact capsule.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: Lisdexamfetamine Dimesylate	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 1, Open-label, Randomized, 3-period Crossover Study Evaluating the Relative Bioavailability of SPD489 When the Contents Are Emptied Into a Soft Food and Orange Juice in Healthy Adult Subjects
• Actual Study Start Date: Jul 15, 2013
• Actual Primary Completion Date: Aug 22, 2013
• Actual Study Completion Date: Aug 22, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lisdexamfetamine Dimesylate Fasting lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions	Drug: Lisdexamfetamine Dimesylate; Single dose of a 70 mg capsule on Day 1; Other Names: SPD489
Experimental: Lisdexamfetamine Dimesylate Vanilla Yogurt Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt	Drug: Lisdexamfetamine Dimesylate; Single dose of a 70 mg capsule on Day 1; Other Names: SPD489
Experimental: Lisdexamfetamine Dimesylate Orange Juice Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice	Drug: Lisdexamfetamine Dimesylate; Single dose of a 70 mg capsule on Day 1; Other Names: SPD489

Outcome Measures

Primary Outcome Measures

1. Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate [Up to 96 hours post-dose]

   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.

2. Maximum Plasma Concentration (Cmax) for Lisdexamfetamine Dimesylate [Up to 96 hours post-dose]

   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.

3. AUC for D-amphetamine [Up to 96 hours post-dose]

   d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.

4. Cmax for D-amphetamine [Up to 96 hours-post-dose]

   d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Age 18-55 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the first screening visit.

2. Willingness to comply with any applicable contraceptive requirements fo the protocol and is:

• Male, or

• Non pregnant, non lactating female

• Females must be at least 90 days post partum or nulliparous

1. Must be considered "healthy". Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram, hematology, blood chemistry, and urinalysis.

2. An understanding, ability, and willingness to fully comply with study procedures and restrictions

3. Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with International Conference on harmonisation Good Clinical Practice Guideline E6 (1996) and applicable regulations, before completing any study related procedures

4. A body mass index between 18.5-30.0kg/m² inclusive. This inclusion criterion will only be assessed at the first screening visit.

5. A hemoglobin value of >=12.0g/dL at the Screening Visit and on Day -1 of Treatment Period 1.

6. Ability to swallow a dose of investigational product according to the study conditions.

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria are met at the

Screening Visit or at Day 1 of Treatment Period 1 (if reassessed):

1. Current or recurrent disease (eg, cardiovascular, renal, liver, gastrointestinal, malignancy, or other conditions) that could affect the action, absorption, or disposition of the investigational products, or could affect clinical or laboratory assessments.

2. Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully comply with the requirements of the study or complete the study, or any condition that presents undue risk from the investigational product or study procedures.

3. Significant illness, as judged by the investigator, within 2 weeks of the first dose of investigational product.

4. History of significant anxiety, tension, or agitation as assessed by the investigator.

5. History of or current diagnosis of glaucoma.

6. History of a seizure disorder (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or known family history of Tourette's Disorder.

7. History or presence of known structural cardiac abnormalities, syncope, cardiac conduction problems, exercise-related cardiac events, or clinically significant bradycardia.

8. History of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, transient ischemic attack or stroke or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug.

9. History of controlled or uncontrolled hypertension or a resting supine systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg.

10. Known family history of sudden cardiac death or ventricular arrhythmia.

11. Currently considered a suicide risk, has previously made a suicide attempt, or has a history of, or is currently demonstrating suicidal ideation.

12. Current use of any medication (including prescription, over-the-counter, herbal or homeopathic preparations) with the exception of hormonal replacement therapy or hormonal contraceptives (current use is defined as use within 14 days of first dose of investigational product).

13. Use of any medication known to inhibit or induce the cytochrome P450 (CYP450) enzymes responsible for the metabolism of the investigational product within 14 days of first dose of investigational product.

14. Known or suspected intolerance or hypersensitivity to the investigational product, closely related compounds, or any of the stated ingredients.

15. Known or suspected intolerance or hypersensitivity to orange juice or vanilla yogurt.

16. History of alcohol or other substance abuse within the last year.

17. A positive screen for alcohol or drugs of abuse at the Screening Visit or on Day 1 of Treatment Period 1.

18. Male subjects who consume more than 3 units of alcohol per day. Female subjects who consume more than 2 units of alcohol per day. (1 alcohol unit=1 beer=1 wine [5oz]=one liquor [1.5 oz]=0.75oz alcohol.).

19. A positive human immunodeficiency virus antibody screen, Hepatitis B surface antigen, or Hepatitis C virus antibody screen.

20. Use of tobacco in any form (eg, smoking or chewing) or other nicotine-containing products in any form (eg, gum, patch) within 30 days prior to the first dose of investigational product.

21. Routine consumption of more than 2 units of caffeine per day or subjects who experience caffeine withdrawal headaches or have a history of caffeine withdrawal headaches. (One caffeine unit is contained in the following items: one 6oz cup of coffee, two 12oz cans of cola, one 12oz cup of tea, three 1oz chocolate bars. Decaffeinated coffee, tea, or cola are not considered to contain caffeine).

22. Donation of blood or blood products (eg, plasma or platelets) within 60 days prior to the first dose of investigational product.

23. Use of another investigational product within 30 days prior to receiving the first dose of investigational product or active enrollment in another drug or vaccine clinical study.

24. Substantial changes in eating habits within 30 days prior to receiving the first dose of investigational product, as assessed by the investigator.

25. An inability to follow a standardized diet and meal schedule or inability to fast, as required during the study.

26. Prior screen failure, randomization, participation, or enrollment in this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinical Pharmacology of Miami, Inc	Miami	Florida	United States

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT01890785
• Other Study ID Numbers: SPD489-123
• First Posted: Jul 2, 2013
• Last Update Posted: Jun 3, 2021
• Last Verified: May 1, 2021

• Additional relevant MeSH terms: Lisdexamfetamine Dimesylate

Study Results

Participant Flow

Arm/Group Title	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Sequence 5	Sequence 6
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: 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: First Intervention
STARTED	5	5	5	5	5	5
COMPLETED	5	4	5	5	5	5
NOT COMPLETED	0	1	0	0	0	0

Baseline Characteristics

Arm/Group Title	Sequence 1	Sequence 2	Sequence 3	Sequence 4	Sequence 5	Sequence 6	Total
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 Participants	5	5	5	5	5	5	30
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	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 (Count of Participants)
Between 18 and 65 years, inclusive	5 100%	5 100%	5 100%	5 100%	5 100%	5 100%	30 100%
Sex: Female, Male (Count of Participants)
Female	1 20%	2 40%	1 20%	0 0%	2 40%	2 40%	8 26.7%
Male	4 80%	3 60%	4 80%	5 100%	3 60%	3 60%	22 73.3%
Region of Enrollment (Count of Participants)
UNITED STATES	5 100%	5 100%	5 100%	5 100%	5 100%	5 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate
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

Outcome Measure Data

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
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)
Measure Participants	30	30	30
Mean (Standard Deviation) [ng*hr/ml]	27.0 (7.8)	36.0 (14.2)	38.3 (12.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lisdexamfetamine Dimesylate Mixed in Orange Juice, Lisdexamfetamine Dimesylate Intact Capsule Fasting
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
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
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt, Lisdexamfetamine Dimesylate Intact Capsule Fasting
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
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
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Maximum Plasma Concentration (Cmax) for Lisdexamfetamine Dimesylate
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

Outcome Measure Data

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
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)
Measure Participants	30	30	30
Mean (Standard Deviation) [ng/ml]	24.5 (7.48)	32.2 (11.46)	38.5 (13.07)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lisdexamfetamine Dimesylate Mixed in Orange Juice, Lisdexamfetamine Dimesylate Intact Capsule Fasting
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
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
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt, Lisdexamfetamine Dimesylate Intact Capsule Fasting
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
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
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	AUC for D-amphetamine
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

Outcome Measure Data

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
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)
Measure Participants	30	30	30
Mean (Standard Deviation) [ng*h/ml]	1140.9 (274.1)	1110.1 (252.9)	1180.2 (295.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lisdexamfetamine Dimesylate Mixed in Orange Juice, Lisdexamfetamine Dimesylate Intact Capsule Fasting
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
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
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt, Lisdexamfetamine Dimesylate Intact Capsule Fasting
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
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
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	Cmax for D-amphetamine
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

Outcome Measure Data

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
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)
Measure Participants	30	30	30
Mean (Standard Deviation) [ng/ml]	59.1 (9.47)	59.0 (9.28)	61.0 (10.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Lisdexamfetamine Dimesylate Mixed in Orange Juice, Lisdexamfetamine Dimesylate Intact Capsule Fasting
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
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
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt, Lisdexamfetamine Dimesylate Intact Capsule Fasting
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
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
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Lisdexamfetamine Dimesylate Mixed in Orange Juice		Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt		Lisdexamfetamine Dimesylate Intact Capsule Fasting
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 (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
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%)		0/30 (0%)		0/30 (0%)
Other (Not Including 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	16/30 (53.3%)		17/30 (56.7%)		9/30 (30%)
Gastrointestinal disorders
Dry mouth	3/30 (10%)	3	5/30 (16.7%)	5	3/30 (10%)	3
Metabolism and nutrition disorders
Decreased appetite	9/30 (30%)	9	8/30 (26.7%)	8	3/30 (10%)	3
Nervous system disorders
Dizziness	1/30 (3.3%)	1	2/30 (6.7%)	2	1/30 (3.3%)	1
Headache	4/30 (13.3%)	4	3/30 (10%)	3	4/30 (13.3%)	4
Psychomotor hyperactivity	1/30 (3.3%)	1	2/30 (6.7%)	2	1/30 (3.3%)	1
Psychiatric disorders
Anxiety	0/30 (0%)	0	0/30 (0%)	0	2/30 (6.7%)	2

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.