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

Sponsor:	Shire Pharmaceutical Development
Information provided by:	Shire Pharmaceutical Development
ClinicalTrials.gov Identifier:	NCT00776555

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Lisdexamfetamine Dimesylate Drug: Racemic mixture of dextroamphetamine and lisdexamfetamine	Phase I

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Single Blind (Subject)
Official Title:	A Single-Blind, Randomized Study of the Comparative Drug Likeability and Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as a Solution

Resource links provided by NLM:

Drug Information available for: Dextroamphetamine sulfate Dextroamphetamine Lisdexamfetamine Lisdexamfetamine dimesylate

U.S. FDA Resources

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:

Drug Rating Questionnaire-Subject (DRQ-S), Question 2 [ Time Frame: 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 ] [ Designated as safety issue: No ]
Question 2: How much do you like the effects you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.

Secondary Outcome Measures:

DRQ-S, Question 1 [ Time Frame: 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 ] [ Designated as safety issue: No ]
Question 1: How much do you feel the drug now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.
DRQ-S, Question 3 [ Time Frame: 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 ] [ Designated as safety issue: No ]
Question 3: Do you dislike the drug effect you are feeling now? Questions are rated on a 29-point scale from 1 (not at all) to 29 (an awful lot). The higher the score the stronger the subjective experience. This is a subjective measure of a drug's effect that has been used to assess the abuse potential of drugs.

Enrollment:	3
Study Start Date:	November 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Vyvanse™ 50mg capsule that has been emptied and made into solution	Drug: 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.
Experimental: ADDERALL XR® 20mg capsule that has been emptied, crushed, and made into solution	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.

Arms

Assigned Interventions

Experimental: Vyvanse™

50mg capsule that has been emptied and made into solution

Drug: 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.

Experimental: ADDERALL XR®

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

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.

Detailed Description:

Not required

Eligibility

Ages Eligible for Study:	18 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776555

Locations

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114

Sponsors and Collaborators

Shire Pharmaceutical Development

Investigators

Principal Investigator:

Thomas Spencer, M.D.

Massachusetts General Hospital

More Information

No publications provided

Responsible Party:	Gerald Tremblay, M.D., Shire Pharmaceutical
ClinicalTrials.gov Identifier:	NCT00776555 History of Changes
Other Study ID Numbers:	SPD489-112
Study First Received:	October 20, 2008
Results First Received:	May 5, 2010
Last Updated:	June 4, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Shire Pharmaceutical Development:

Not required

Additional relevant MeSH terms:

Dextroamphetamine
Adderall
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012