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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00776555
• Other study ID #: SPD489-112
• Status: Terminated
• Phase: Phase 1
• Start date: November 21, 2008
• Est. completion date: March 31, 2009

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Not required

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 31, 2009
• Est. primary completion date: March 31, 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug Rating Questionnaire-Subject (DRQ-S), Question 2	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.	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	DRQ-S, Question 1	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.	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	DRQ-S, Question 3	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.	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