Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC

Study Description

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Brief Summary:

The purpose of this study is to determine if taking Vyvanse with Prilosec OTC or Adderall XR with Prilosec OTC changes how quickly the drug is absorbed into the body and/or changes how much of the drug is absorbed into the body.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: Lisdexamfetamine Dimesylate; Drug: Adderall XR (mixed salts amphetamine)	Phase 1

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	24 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	None (Open Label)
Official Title:	A Phase I, Open-Label, Randomized, Four Period Crossover Drug Interaction Study to Evaluate the Pharmacokinetic Profiles of VYVANSE™ and ADDERALL XR When Each is Administered Alone and in Combination With the Proton Pump Inhibitor Prilosec OTC™ in Healthy Adult Volunteers
Study Start Date :	September 2008
Actual Primary Completion Date :	October 2008
Actual Study Completion Date :	October 2008

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Vyvanse (LDX)	Drug: Lisdexamfetamine Dimesylate; 50mg capsule
Experimental: Adderall XR (AXR)	Drug: Adderall XR (mixed salts amphetamine); 20mg capsule

Outcome Measures

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Primary Outcome Measures :

1. Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ]
2. Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ]
3. Area Under the Steady-state Plasma Concentration-time Curve (AUC) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ]
4. Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ]
5. Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ]
6. Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ]
7. AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ]
8. T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ]
9. Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ]
10. Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ]
11. AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ]
12. T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ]

Secondary Outcome Measures :

1. Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC. [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing ]
2. DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing ]
3. DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC [ Time Frame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing ]
4. Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing ]
5. Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing ]
6. Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing ]
7. Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: Pre-dose, 2 and 8 hours after dosing ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 45 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

1. Healthy volunteers, age 18 to 45 inclusive at the time of consent.
2. Male, or non-pregnant, non-lactating female
3. Female subjects must have a negative serum beta Human Chorionic Gonadotropin (HCG) pregnancy test at Screening, and a negative urine pregnancy test on Day -1 after checking into the clinic the day before the first dose of investigational product.
4. Body Mass Index (BMI) between 20.0 and 30.0 kg/m² inclusive. This inclusion criterion will only be assessed at the first screening visit.
5. Satisfactory medical assessment with no significant or relevant abnormality in medical history, physical examination (PE), vital signs and laboratory evaluation
6. Normal or clinically insignificant Screening ECG findings as assessed by the Investigator.
7. Ability to swallow investigational products.

Exclusion Criteria:

1. Current or recurrent disease that could affect the action, absorption or disposition of the investigational products, or could affect clinical or laboratory assessments.
2. Current or relevant previous 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 products 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 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.
8. History of controlled or uncontrolled hypertension or a resting sitting systolic blood pressure >139mmHg or diastolic blood pressure >89mmHg.
9. Known family history of sudden cardiac death or ventricular arrhythmia.
10. Currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently demonstrating suicidal ideation.
11. Current use of any medication (including prescription, over the counter [OTC], 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).
12. Use of any medication known to inhibit or induce the CYP450 enzymes responsible for the metabolism of the investigational products within 14 days of first dose of investigational product.
13. Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds or any of the stated ingredients.
14. History of alcohol or other substance abuse within the last year.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Florida
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States, 33014

Sponsors and Collaborators

Shire

Investigators

Principal Investigator:	Kenneth C. Lasseter, MD	Clinical Pharmacology of Miami, Inc

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

FDA recall information 

Publications of Results:

Haffey MB, Buckwalter M, Zhang P, Homolka R, Martin P, Lasseter KC, Ermer JC. Effects of omeprazole on the pharmacokinetic profiles of lisdexamfetamine dimesylate and extended-release mixed amphetamine salts in adults. Postgrad Med. 2009 Sep;121(5):11-9. doi: 10.3810/pgm.2009.09.2048.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wigal T, Brams M, Gasior M, Gao J, Giblin J. Effect size of lisdexamfetamine dimesylate in adults with attention-deficit/hyperactivity disorder. Postgrad Med. 2011 Mar;123(2):169-76. doi: 10.3810/pgm.2011.03.2275.

Responsible Party:	Gerald Tremblay, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00746733 History of Changes
Other Study ID Numbers:	SPD489-113
First Posted:	September 4, 2008
Results First Posted:	November 17, 2009
Last Update Posted:	November 20, 2009
Last Verified:	November 2009

Keywords provided by Shire:

Drug; Interaction; Study

Additional relevant MeSH terms:

Amphetamine; Lisdexamfetamine Dimesylate; Adderall; Omeprazole; Central Nervous System Stimulants; Physiological Effects of Drugs; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Dopamine Agents; Neurotransmitter Agents	Molecular Mechanisms of Pharmacological Action; Adrenergic Agents; Adrenergic Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Uptake Inhibitors; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors