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

NCT00776555 | Terminated Phase 1 Results

• 1 other identifier: SPD489-112
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Not required

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• DRQ-S, Question 1

  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

• DRQ-S, Question 3

  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

Study Arms (2)

Vyvanse™

EXPERIMENTAL

50mg capsule that has been emptied and made into solution

Drug: Lisdexamfetamine Dimesylate

ADDERALL XR®

EXPERIMENTAL

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

Drug: Racemic mixture of dextroamphetamine and lisdexamfetamine

Interventions

Lisdexamfetamine Dimesylate 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.

Vyvanse™

Racemic mixture of dextroamphetamine and lisdexamfetamine 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.

ADDERALL XR®

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Interventions

Lisdexamfetamine Dimesylate

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Limitations and Caveats

Shire decided to cancel this study on march 31, 2009 due to changes in business priorities. The study termination was not related to any data or safety concerns.

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2008
• First Posted: October 21, 2008
• Study Start: November 21, 2008
• Primary Completion: March 31, 2009
• Study Completion: March 31, 2009
• Last Updated: June 9, 2021
• Results First Posted: July 7, 2010

Record last verified: 2021-05

Locations

US (1)