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

NCT ID: NCT00776555

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-21
• Study Completion Date: 2009-03-31

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

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Vyvanse™

50mg capsule that has been emptied and made into solution

Group Type: EXPERIMENTAL

Lisdexamfetamine Dimesylate

Intervention Type: DRUG

Study is a two-period cross-over design where subjects will have 2 Screening visits, a Baseline visit, and then be enrolled into the study for 2 Periods. Each Period has 2-3 visits and lasts from 2-6 weeks. At each Period visit subjects will be given one of the two treatment arm drugs that have been solubilized and then have blood drawn for pharmacokinetic analysis and the Drug Rating Questionnaire administered. At the end of Period 1 subjects will be crossed-over to the alternative treatment drug for the Period 2. The Vyvanse™ capsule contents will emptied into water to make a solution and given to subjects to drink at the beginning of each Period visit.

ADDERALL XR®

20mg capsule that has been emptied, crushed, and made into solution

Group Type: EXPERIMENTAL

Racemic mixture of dextroamphetamine and lisdexamfetamine

Intervention Type: DRUG

Same visits as described for Vyvanse™. The ADDERALL XR® capsule contents will be crushed, solubilized with water, and given to subjects to drink prior to pharmacokinetic blood draws and DRQ-S administration over the course of two periods.

Interventions

Lisdexamfetamine Dimesylate

Study is a two-period cross-over design where subjects will have 2 Screening visits, a Baseline visit, and then be enrolled into the study for 2 Periods. Each Period has 2-3 visits and lasts from 2-6 weeks. At each Period visit subjects will be given one of the two treatment arm drugs that have been solubilized and then have blood drawn for pharmacokinetic analysis and the Drug Rating Questionnaire administered. At the end of Period 1 subjects will be crossed-over to the alternative treatment drug for the Period 2. The Vyvanse™ capsule contents will emptied into water to make a solution and given to subjects to drink at the beginning of each Period visit.

Intervention Type: DRUG

Racemic mixture of dextroamphetamine and lisdexamfetamine

Same visits as described for Vyvanse™. The ADDERALL XR® capsule contents will be crushed, solubilized with water, and given to subjects to drink prior to pharmacokinetic blood draws and DRQ-S administration over the course of two periods.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

SPD489-112

Identifier Type: -

Identifier Source: org_study_id