Clinical trial NCT00746733: Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Drug
Interaction
Study
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2008-09-04
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
timeFrame: 0 through 96 hours after dosing
measure: Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
timeFrame: 0 through 96 hours after dosing
measure: 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
timeFrame: 0 through 96 hours after dosing
measure: Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
timeFrame: 0 through 96 hours after dosing
measure: Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
timeFrame: 0 through 96 hours after dosing
measure: Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
timeFrame: 0 through 96 hours after dosing
measure: AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
timeFrame: 0 through 96 hours after dosing
measure: T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
timeFrame: 0 through 96 hours after dosing
measure: Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
timeFrame: 0 through 96 hours after dosing
measure: Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
timeFrame: 0 through 96 hours after dosing
measure: AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
timeFrame: 0 through 96 hours after dosing
measure: T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC
timeFrame: 0 through 96 hours after dosing
Secondary outcomes:
measure: Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.
timeFrame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing
measure: DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC
timeFrame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing
measure: DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC
timeFrame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing
measure: Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
timeFrame: Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing
measure: Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
timeFrame: Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing
measure: Pulse Rate for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
timeFrame: Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing
measure: Electrocardiogram Results (QTcF Interval) for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC
timeFrame: Pre-dose, 2 and 8 hours after dosing
Other outcomes:
Locations:
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, Inc.
state: Florida
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.