Clinical trial NCT00776555: Compare Subjective Drug Liking & Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as an Oral Solution
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: Not required
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2008-10-21
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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

Detailed description: Not required

Eligibility 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

Primary outcomes:
measure: Drug Rating Questionnaire-Subject (DRQ-S), Question 2
timeFrame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose
Secondary outcomes:
measure: DRQ-S, Question 1
timeFrame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose
measure: DRQ-S, Question 3
timeFrame: Pre-dose and 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 7, 8, 12 and 24 hours post-dose
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: