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

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00746733
First received: September 2, 2008
Last updated: November 18, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Healthy Volunteers
Drug: Lisdexamfetamine Dimesylate
Drug: Adderall XR (mixed salts amphetamine)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ] [ Designated as safety issue: No ]
  • Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ] [ Designated as safety issue: No ]
  • AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ] [ Designated as safety issue: No ]
  • T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ] [ Designated as safety issue: No ]
  • Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ] [ Designated as safety issue: No ]
  • Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ] [ Designated as safety issue: No ]
  • AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ] [ Designated as safety issue: No ]
  • T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC [ Time Frame: 0 through 96 hours after dosing ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: September 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vyvanse (LDX) Drug: Lisdexamfetamine Dimesylate
50mg capsule
Experimental: Adderall XR (AXR) Drug: Adderall XR (mixed salts amphetamine)
20mg capsule

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746733

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

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gerald Tremblay, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier: NCT00746733     History of Changes
Other Study ID Numbers: SPD489-113
Study First Received: September 2, 2008
Results First Received: October 14, 2009
Last Updated: November 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
Drug
Interaction
Study

Additional relevant MeSH terms:
Amphetamine
Adderall
Dextroamphetamine
Omeprazole
Proton Pump Inhibitors
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014