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Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE (lisdexamfetamine dimesylate) when given alone, and in combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: SPD503 (4mg) | Active Comparator |
| |
| B: VYVANSE (50mg) | Active Comparator |
| |
| C: SPD503 (4mg) + VYVANSE (50mg) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPD503 | Drug | SPD503 extended-release 4mg orally administered tablets. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken. |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of Guanfacine | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | |
| Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | |
| Time of Maximum Plasma Concentration (Tmax) of Guanfacine | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | |
| Time of Plasma Half-Life(T 1/2) of Guanfacine | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | |
| Cmax of d-Amphetamine | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | |
| AUC of d-Amphetamine | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | |
| Tmax of d-Amphetamine | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | |
| T 1/2 of d-Amphetamine | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Biomedical Research, Inc. | Hackensack | New Jersey | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23615868 | Result | Roesch B, Corcoran ME, Fetterolf J, Haffey M, Martin P, Preston P, Purkayastha J, Wang P, Ermer J. Pharmacokinetics of coadministered guanfacine extended release and lisdexamfetamine dimesylate. Drugs R D. 2013 Jun;13(2):119-28. doi: 10.1007/s40268-013-0014-8. |
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Study consists of 3 treatment periods performed in 6 dosing sequences: SPD503 (extended-release guanfacine HCl) single 4 mg dose, Vyvanse (lisdexamfatamine dimesylate ) single 50 mg dose, and SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered. There is a washout period between each treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse | SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention |
| FG001 | SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse | SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention |
| FG002 | Vyvanse First, Then SPD503, Then SPD503 + Vyvanse | Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention |
| FG003 | Vyvanse First, Then SPD503 + Vyvanse, Then SPD503 | Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention |
| FG004 | SPD503 + Vyvanse First, Then SPD503, Then Vyvanse | SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention |
| FG005 | SPD503 + Vyvanse, Then Vyvanse, Then SPD503 | SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention |
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| Washout |
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| Second Intervention |
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| Washout |
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| Third Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse | SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention |
| BG001 | SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Maximum Plasma Concentration (Cmax) of Guanfacine | Pharmacokinetic Population (PKP) consists of all subjects in the Safety Population who had evaluable concentration-time profiles for guanfacine or d-amphetamine. The Safety Population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment. | Posted | Mean | Standard Deviation | ng/ml | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose |
|
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Safety population consists of all subjects who received at least 1 dose of study drug and had at least 1 post-dose safety assessment.
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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 | SPD503 Alone | Single 4 mg dose of extended-release Guanfacine HCl |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system 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 |
|---|---|
| D016316 | Guanfacine |
| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
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|
|
| VYVANSE | Drug | VYVANSE 50mg orally administered capsules. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken. |
|
|
| SPD503 and VYVANSE | Drug | SPD503 4mg tablets + VYVANSE 50mg capsules orally administered together. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken. |
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| Physician Decision |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention |
| BG002 | Vyvanse First, Then SPD503, Then SPD503 + Vyvanse | Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention |
| BG003 | Vyvanse First, Then SPD503 + Vyvanse, Then SPD503 | Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention |
| BG004 | SPD503 + Vyvanse First, Then SPD503, Then Vyvanse | SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention |
| BG005 | SPD503 + Vyvanse, Then Vyvanse, Then SPD503 | SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| Primary | Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Guanfacine | PKP | Posted | Mean | Standard Deviation | ng*h/ml | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose |
|
|
|
| Primary | Time of Maximum Plasma Concentration (Tmax) of Guanfacine | PKP | Posted | Mean | Standard Deviation | hours | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose |
|
|
|
| Primary | Time of Plasma Half-Life(T 1/2) of Guanfacine | PKP | Posted | Mean | Standard Deviation | hours | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose |
|
|
|
| Primary | Cmax of d-Amphetamine | PKP | Posted | Mean | Standard Deviation | ng/ml | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose |
|
|
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| Primary | AUC of d-Amphetamine | PKP | Posted | Mean | Standard Deviation | ng*h/ml | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose |
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|
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| Primary | Tmax of d-Amphetamine | PKP | Posted | Mean | Standard Deviation | hours | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose |
|
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| Primary | T 1/2 of d-Amphetamine | PKP | Posted | Mean | Standard Deviation | hours | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose |
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|
|
| 0 |
| 40 |
| 9 |
| 40 |
| EG001 | Vyvanse Alone | Single 50 mg dose | 0 | 41 | 6 | 41 |
| EG002 | SPD503 + Vyvanse | SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered | 0 | 41 | 6 | 41 |
| Dizziness Postural | Nervous system disorders |
|
| Headache | Nervous system 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.
| D000146 |
| Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |