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Compare the pharmacokinetic profiles when the contents are emptied into a soft food and orange juice compared to the SPD489 when swallowed as an intact capsule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lisdexamfetamine Dimesylate Fasting | Experimental | lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions |
|
| Lisdexamfetamine Dimesylate Vanilla Yogurt | Experimental | Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt |
|
| Lisdexamfetamine Dimesylate Orange Juice | Experimental | Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylate | Drug | Single dose of a 70 mg capsule on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate | AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. | Up to 96 hours post-dose |
| Maximum Plasma Concentration (Cmax) for Lisdexamfetamine Dimesylate | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. | Up to 96 hours post-dose |
| AUC for D-amphetamine | d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity. | Up to 96 hours post-dose |
| Cmax for D-amphetamine | d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity. | Up to 96 hours-post-dose |
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Inclusion Criteria:
Age 18-55 years inclusive at the time of consent. The date of signing informed consent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the first screening visit.
Willingness to comply with any applicable contraceptive requirements fo the protocol and is:
Must be considered "healthy". Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead electrocardiogram, hematology, blood chemistry, and urinalysis.
An understanding, ability, and willingness to fully comply with study procedures and restrictions
Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with International Conference on harmonisation Good Clinical Practice Guideline E6 (1996) and applicable regulations, before completing any study related procedures
A body mass index between 18.5-30.0kg/m² inclusive. This inclusion criterion will only be assessed at the first screening visit.
A hemoglobin value of >=12.0g/dL at the Screening Visit and on Day -1 of Treatment Period 1.
Ability to swallow a dose of investigational product according to the study conditions.
Exclusion Criteria:
Subjects are excluded from the study if any of the following criteria are met at the Screening Visit or at Day 1 of Treatment Period 1 (if reassessed):
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami, Inc | Miami | Florida | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27661399 | Result | Ermer J, Corcoran M, Lasseter K, Martin PT. Relative Bioavailabilities of Lisdexamfetamine Dimesylate and D-Amphetamine in Healthy Adults in an Open-Label, Randomized, Crossover Study After Mixing Lisdexamfetamine Dimesylate With Food or Drink. Ther Drug Monit. 2016 Dec;38(6):769-776. doi: 10.1097/FTD.0000000000000343. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sequence 1 | Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention |
| FG001 | Sequence 2 | Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention |
| FG002 | Sequence 3 | Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention |
| FG003 | Sequence 4 | Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention |
| FG004 | Sequence 5 | Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention |
| FG005 | Sequence 6 | Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
| |||||||||||||
| Second Intervention |
| |||||||||||||
| Third Intervention |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sequence 1 | Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Plasma Concentration-time Curve (AUC) for Lisdexamfetamine Dimesylate | AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body. | Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | Posted | Mean | Standard Deviation | ng*hr/ml | Up to 96 hours post-dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lisdexamfetamine Dimesylate Mixed in Orange Juice | Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
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|
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Sequence 2 |
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention |
| BG002 | Sequence 3 | Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention |
| BG003 | Sequence 4 | Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention |
| BG004 | Sequence 5 | Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention |
| BG005 | Sequence 6 | Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention |
| BG006 | Total | Total of all reporting groups |
| Years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt |
Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1) |
| OG002 | Lisdexamfetamine Dimesylate Intact Capsule Fasting | Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1) |
|
|
|
| Primary | Maximum Plasma Concentration (Cmax) for Lisdexamfetamine Dimesylate | Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated. | Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | Posted | Mean | Standard Deviation | ng/ml | Up to 96 hours post-dose |
|
|
|
|
| Primary | AUC for D-amphetamine | d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity. | Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | Posted | Mean | Standard Deviation | ng*h/ml | Up to 96 hours post-dose |
|
|
|
|
| Primary | Cmax for D-amphetamine | d-Amphetamine is a metabolite of Lisdexamfetamine Dimesylate and is an active form that is responsible for the drug's therapeutic activity. | Pharmacokinetic Set consisted of all subjects in the Safety Set for whom the primary pharmacokinetic data were considered sufficient and interpretable. Safety Set consisted of subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | Posted | Mean | Standard Deviation | ng/ml | Up to 96 hours-post-dose |
|
|
|
|
| 0 |
| 30 |
| 16 |
| 30 |
| EG001 | Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt | Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt(Single dose of a 70 mg capsule on Day 1) | 0 | 30 | 17 | 30 |
| EG002 | Lisdexamfetamine Dimesylate Intact Capsule Fasting | Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1) | 0 | 30 | 9 | 30 |
| Decreased appetite | Metabolism and nutrition disorders |
|
| Dizziness | Nervous system disorders |
|
| Headache | Nervous system disorders |
|
| Psychomotor hyperactivity | Nervous system disorders |
|
| Anxiety | Psychiatric disorders |
|
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.
| D005021 |
| Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| Ratio of geometric least squares means |
| 0.828 |
| 2-Sided |
| 90 |
| 0.752 |
| 0.912 |
| Superiority or Other (legacy) |
| Ratio of geometric least squares means |
| 0.944 |
| 2-Sided |
| 90 |
| 0.912 |
| 0.977 |
| Superiority or Other (legacy) |
| Ratio of geometric least squares means |
| 0.970 |
| 2-Sided |
| 90 |
| 0.944 |
| 0.997 |
| Superiority or Other (legacy) |