Compare Subjective Drug Liking & Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as an Oral Solution

Condition(s) targeted: Healthy

Intervention: Lisdexamfetamine Dimesylate (Drug); Racemic mixture of dextroamphetamine and lisdexamfetamine (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Shire Pharmaceutical Development

Official(s) and/or principal investigator(s):
Thomas Spencer, M.D., Principal Investigator, Affiliation: Massachusetts General Hospital

Overall contact:
Shire Call Center, Phone: +1 866-842-5335

The purpose of this study is to compare subjective drug liking using the Drug Rating Questionnaire, subject version (DRQ-S), question 2 and pharmacokinetics of Vyvanse™ and ADDERALL XR® when administered as an oral solution.

Hypothesis: DRQ-S, question 2 will show no difference between the two drugs

Official title: A Single-Blind, Randomized Study of the Comparative Drug Likeability and Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as a Solution

Study design: Other, Randomized, Single Blind (Subject), Active Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Primary outcome: Drug Rating Questionnaire, subject version, question 2

Secondary outcome: Drug Rating Questionnaire, subject version, questions 1 and 3

Detailed description: Not required

Minimum age: 18 Years. Maximum age: 25 Years. Gender(s): Both.

Criteria:

Inclusion Criteria

- Healthy young adults, male or female (non-pregnant and non-lactating), age 18-25 years

at time of consent

- Have a body mass index (BMI) between 20. 0 and 29. 0kg/m2

- Satisfactory medical assessment with no clinically significant or relevant

- Subject must demonstrate a positive response to amphetamine at Screening

Exclusion Criteria

- A history of current or recurrent disease that could have an effect on the study

- Subject has a history of seizures, any tic disorder, or a current diagnosis and/or a

known family history of Tourette's Disorder

- Subject has a concurrent chronic or acute illness or other condition that might

confound the results of safety assessments or that might increase risk to the subject

- Subject has any clinically significant ECG and/or laboratory abnormalities

- Subject has a documented allergy, hypersensitivity or intolerance to amphetamines

- Subject has been prescribed or has taken amphetamine products in the past, including

childhood; recreational use may not be exclusionary per the Investigator's discretion

- Subject has a known family history of sudden cardiac death or ventricular arrhythmia

- Subject has a recent history (within the past 6 months) of suspected substance abuse

or dependence disorder (excluding nicotine)

- Subject has participated in any investigational clinical or vaccine trial within 30

days prior to the first dose of study drug

- Subjects is currently considered a suicide risk, has previously made a suicide attempt

or has a prior history of, or is currently demonstrating suicidal ideation

Shire Call Center, Phone: +1 866-842-5335

Massachusetts General Hospital, Boston, Massachusetts 02114, United States; Recruiting
Shire Call Center, Phone: 866-842-5335
Thomas Spencer, M.D., Principal Investigator

Starting date: November 2008
Ending date: October 2009
Last updated: January 15, 2009