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

• Sponsor: Shire (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00776555
• Collaborator: (none)
• Enrollment: 3
• Location: 1
• Arms: 2
• Actual Duration (Months): 4.3
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: Lisdexamfetamine Dimesylate; Drug: Racemic mixture of dextroamphetamine and lisdexamfetamine	Phase 1

Detailed Description

Not required

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: A Single-Blind, Randomized Study of the Comparative Drug Likeability and Pharmacokinetics of Vyvanse™ and ADDERALL XR® When Administered as a Solution
• Actual Study Start Date: Nov 21, 2008
• Actual Primary Completion Date: Mar 31, 2009
• Actual Study Completion Date: Mar 31, 2009

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Drug Rating Questionnaire-Subject (DRQ-S), Question 2 [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]

   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

1. 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]

   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.

2. 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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Shire

Investigators

• Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT00776555
• Other Study ID Numbers: SPD489-112
• First Posted: Oct 21, 2008
• Last Update Posted: Jun 9, 2021
• Last Verified: May 1, 2021

• Keywords provided by Shire: Not required
• Additional relevant MeSH terms: Lisdexamfetamine Dimesylate; Dextroamphetamine

Study Results

Participant Flow

Recruitment Details	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.

Arm/Group Title	Vyvanse First	ADDERALL XR First
Arm/Group Description	Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention	Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
Period Title: Overall Study
STARTED	3	0
COMPLETED	0	0
NOT COMPLETED	3	0

Baseline Characteristics

Arm/Group Title	Vyvanse First	ADDERALL XR First	Total
Arm/Group Description	Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention	Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention	Total of all reporting groups
Overall Participants	3	0	3
Age (Count of Participants)
<=18 years	0 0%	0 NaN
Between 18 and 65 years	3 100%	3 Infinity
>=65 years	0 0%	0 NaN
Sex: Female, Male (Count of Participants)
Female	1 33.3%	1 Infinity
Male	2 66.7%	2 Infinity
Region of Enrollment (Count of Participants)
United States	3 100%	3 Infinity

Outcome Measures

1. Primary Outcome

Title	Drug Rating Questionnaire-Subject (DRQ-S), Question 2
Description	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.
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

Outcome Measure Data

Analysis Population Description

Analysis not performed because of the study's premature termination.

Arm/Group Title	Vyvanse First	ADDERALL XR First
Arm/Group Description	Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention	Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
Measure Participants	0	0

2. Secondary Outcome

Title	DRQ-S, Question 1
Description	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.
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

Outcome Measure Data

Analysis Population Description

Analysis not performed because of the study's premature termination.

Arm/Group Title	Vyvanse First	ADDERALL XR First
Arm/Group Description	Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention	Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
Measure Participants	0	0

3. Secondary Outcome

Title	DRQ-S, Question 3
Description	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.
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

Outcome Measure Data

Analysis Population Description

Analysis not performed because of the study's premature termination.

Arm/Group Title	Vyvanse First	ADDERALL XR First
Arm/Group Description	Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention	Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
Measure Participants	0	0

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	Note: At the time of the premature termination, only 3 participants had been enrolled into this study. All 3 participants were randomized to receive VYVANSE in Period 1 of this study, and ADDERALL XR in Period 2 of this study. None of the study participants advanced to Period 2, therefore none received ADDERALL XR.
Arm/Group Title	Vyvanse First		ADDERALL XR First
Arm/Group Description	Vyvanse 50mg capsule that has been emptied and made into an oral solution in first intervention, washout, then Adderall XR20mg capsule that has been emptied, crushed, and made into an oral solution in second intervention		Adderall XR 20mg capsule that has been emptied, crushed, and made into an oral solution in the first intervention, washout, then Vyvanse 50mg capsule that has been emptied and made into an oral solution in second intervention
All Cause Mortality
	Vyvanse First		ADDERALL XR First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Vyvanse First		ADDERALL XR First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Vyvanse First		ADDERALL XR First
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/3 (66.7%)		0/0 (NaN)
Infections and infestations
Upper respiratory infection	1/3 (33.3%)		0/0 (NaN)
Nervous system disorders
Headache	1/3 (33.3%)		0/0 (NaN)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.