Healthy
Conditions
Keywords
Not required
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
Interventions
DRUGLisdexamfetamine 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.
DRUGRacemic 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.
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
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.
Participants by arm
| Arm | Count |
|---|---|
| Vyvanse First 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 | 3 |
| ADDERALL XR First 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 | 0 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Study terminated | 3 | 0 |
Baseline characteristics
| Characteristic | Vyvanse First | Total |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants |
| Region of Enrollment United States | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 3 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 |
Outcome results
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.
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
Population: Analysis not performed because of the study's premature termination.
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.
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
Population: Analysis not performed because of the study's premature termination.
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.
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
Population: Analysis not performed because of the study's premature termination.