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This is a drug-drug interaction study; the purpose of this study is to examine the pharmacokinetics (levels of drug in the blood) of SPD503 (guanfacine hydrochloride) and Concerta (methylphenidate HCl) when given alone, and in combination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPD503 | Experimental |
| |
| Concerta | Active Comparator |
| |
| SPD503 + Concerta | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPD503 | Drug | SPD503 (guanfacine hydrochloride) extended-release 4 mg orally administered tablets |
|
| 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-Methylphenidate | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | |
| AUC of d-Methylphenidate | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | |
| Tmax of d-Methylphenidate | 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 30, 48 and 72 hours post-dose | |
| T 1/2 of d-Methylphenidate | 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 | 07601 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23519656 | Result | Roesch B, Corcoran M, Haffey M, Stevenson A, Wang P, Purkayastha J, Martin P, Ermer J. Pharmacokinetics of coadministration of guanfacine extended release and methylphenidate extended release. Drugs R D. 2013 Mar;13(1):53-61. doi: 10.1007/s40268-013-0009-5. |
| Label | URL |
|---|---|
| FDA recall information | View source |
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Study consists of 3 regimens: SPD503 (extended-release guanfacine HCl) single 4 mg dose, Concerta (extended-release methylphenidate HCl) single 36 mg dose, and SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered. Each dosing regimen is separated by a washout period and performed in 6 different dosing sequences.
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| ID | Title | Description |
|---|---|---|
| FG000 | SPD503 First, Then Concerta, Then SPD503 + Concerta | SPD503 single 4 mg dose in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention |
| FG001 | SPD503 First, Then SPD503 + Concerta, Then Concerta | SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, Concerta single 36 mg dose in third intervention |
| FG002 | Concerta First, Then SPD503, Then SPD503 + Concerta | Concerta single 36 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention |
| FG003 | Concerta First, Then SPD503 + Concerta, Then SPD503 | Concerta single 36 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention |
| FG004 | SPD503 + Concerta First, Then SPD503, Then Concerta | SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Concerta single 36 mg dose in third intervention |
| FG005 | SPD503 + Concerta First, Then Concerta, Then SPD503 | SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, Concerta single 36 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 Concerta, Then SPD503 + Concerta | SPD503 single 4 mg dose in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention |
| BG001 | SPD503 First, Then SPD503 + Concerta, Then Concerta |
| 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-methylphenidate. 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 (SP) consisted 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Orthostatic syncope | Nervous system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | 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 |
|---|---|
| D016316 | Guanfacine |
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D010648 | Phenylacetates |
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| Concerta | Drug | CONCERTA (methylphenidate HCl) extended-release 36 mg orally administered tablets. |
|
| SPD503 + Concerta | Drug | SPD503 4 mg + CONCERTA 36 mg orally administered tablets (taken together). |
|
| FDA-approved label | View source |
| 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) + Concerta (single 36 mg dose) coadministered in second intervention, washout, Concerta single 36 mg dose in third intervention |
| BG002 | Concerta First, Then SPD503, Then SPD503 + Concerta | Concerta single 36 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention |
| BG003 | Concerta First, Then SPD503 + Concerta, Then SPD503 | Concerta single 36 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention |
| BG004 | SPD503 + Concerta First, Then SPD503, Then Concerta | SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Concerta single 36 mg dose in third intervention |
| BG005 | SPD503 + Concerta First, Then Concerta, Then SPD503 | SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, Concerta single 36 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 |
|
|
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| 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-Methylphenidate | 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 |
|
|
|
| Primary | AUC of d-Methylphenidate | 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 | Tmax of d-Methylphenidate | 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 | T 1/2 of d-Methylphenidate | 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 |
|
|
|
| 1 |
| 37 |
| 6 |
| 37 |
| EG001 | Concerta Alone | Single 36 mg dose of extended-release methylphenidate HCl | 0 | 38 | 8 | 38 |
| EG002 | SPD503 + Concerta | SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered | 0 | 37 | 4 | 37 |
| Dizziness | Nervous system disorders |
|
| 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 |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |