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

NCT00746733 | Completed Phase 1 Results

• 1 other identifier: SPD489-113
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

Drug; Interaction; Study

Outcome Measures

Primary Outcomes (12)

• Maximum Plasma Concentration (Cmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

  d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.

  0 through 96 hours after dosing

• Time of Maximum Plasma Concentration (Tmax) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

  d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.

  0 through 96 hours after dosing

• 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

  d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.

  0 through 96 hours after dosing

• Terminal Half-life (T 1/2) of d-Amphetamine for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

  d-Amphetamine is an isomer of Vyvanse and Adderall XR and is an active form that is responsible for the drug's therapeutic activity.

  0 through 96 hours after dosing

• Cmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

  l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.

  0 through 96 hours after dosing

• Tmax of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

  l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.

  0 through 96 hours after dosing

• AUC of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

  0 through 96 hours after dosing

• T 1/2 of l-Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

  l-Amphetamine is an isomer of Adderall XR and is an active form that is responsible for the drug's therapeutic activity.

  0 through 96 hours after dosing

• Cmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

  Total amphetamine is the d- and l-amphetamines.

  0 through 96 hours after dosing

• Tmax of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

  Total amphetamine is the d- and l-amphetamines.

  0 through 96 hours after dosing

• AUC of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

  Total amphetamine is the d- and l-amphetamines.

  0 through 96 hours after dosing

• T 1/2 of Total Amphetamine for Adderall XR Alone and in Combination With Prilosec OTC

  Total amphetamine is the d- and l-amphetamines.

  0 through 96 hours after dosing

Secondary Outcomes (7)

• Drug Rating Questionnaire-Subject (DRQ-S), Question 2, for Vyvanse and Adderall XR in Combination With Prilosec OTC.

  Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing

• DRQ-S, Question 1, for Vyvanse and Adderall XR in Combination With Prilosec OTC

  Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing

• DRQ-S, Question 3, for Vyvanse and Adderall XR in Combination With Prilosec OTC

  Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 and 24 hours after dosing

• Systolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

  Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing

• Diastolic Blood Pressure for Vyvanse and Adderall XR Alone and in Combination With Prilosec OTC

  Pre-dose and 1, 2, 4, 8, 12, 24, 48, 72 and 96 hours after dosing

Study Arms (2)

Vyvanse (LDX)

EXPERIMENTAL

Drug: Lisdexamfetamine Dimesylate

Adderall XR (AXR)

EXPERIMENTAL

Drug: Adderall XR (mixed salts amphetamine)

Interventions

Lisdexamfetamine Dimesylate DRUG

50mg capsule

Vyvanse (LDX)

Adderall XR (mixed salts amphetamine) DRUG

20mg capsule

Adderall XR (AXR)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy volunteers, age 18 to 45 inclusive at the time of consent.
• Male, or non-pregnant, non-lactating female
• 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.
• Satisfactory medical assessment with no significant or relevant abnormality in medical history, physical examination (PE), vital signs and laboratory evaluation
• Normal or clinically insignificant Screening ECG findings as assessed by the Investigator.
• Ability to swallow investigational products.

You may not qualify if:

• Current or recurrent disease that could affect the action, absorption or disposition of the investigational products, or could affect clinical or laboratory assessments.
• 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.
• Significant illness, as judged by the Investigator, within 2 weeks of the first dose of investigational product.
• History of significant anxiety, tension or agitation as assessed by the Investigator.
• History of or current diagnosis of glaucoma.
• 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.
• 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.
• History of controlled or uncontrolled hypertension or a resting sitting systolic blood pressure \>139mmHg or diastolic blood pressure \>89mmHg.
• Known family history of sudden cardiac death or ventricular arrhythmia.
• Currently considered a suicide risk, has previously made a suicide attempt or has a prior history of, or is currently demonstrating suicidal ideation.
• 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).
• 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.
• Known or suspected intolerance or hypersensitivity to the investigational product(s), closely related compounds or any of the stated ingredients.
• History of alcohol or other substance abuse within the last year.

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

Clinical Pharmacology of Miami, Inc.

Miami, Florida, 33014, United States

Location

Related Publications (2)

• 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.

  PMID: 19820270 RESULT

• 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.

  PMID: 21474905 DERIVED

Related Links

• FDA recall information

MeSH Terms

Interventions

Lisdexamfetamine Dimesylate; SLI381

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2008
• First Posted: September 4, 2008
• Study Start: September 8, 2008
• Primary Completion: October 26, 2008
• Study Completion: October 26, 2008
• Last Updated: June 14, 2021
• Results First Posted: November 17, 2009

Record last verified: 2021-06

Locations

US (1)