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To assess the pharmacokinetics of a single dose of Aptensio XR® (methylphenidate hydrochloride extended-release) capsules under fed conditions in male or female children 4 to under 6 years of age with ADHD.
This will be a multi-center, open-label, single-dose, study to assess the pharmacokinetics of Aptensio XR® (methylphenidate hydrochloride extended-release) capsules in male and female children 4 to under 6 years of age with ADHD in fed condition.
Screening Procedures: After obtaining written informed consent from parents, subjects will undergo a complete medical and medication history, demographic data (including sex, age, race, ethnicity, body weight (kg), height (cm), Body Mass Index (BMI) (kg/m2), physical examination, vital signs evaluation (sitting blood pressure, pulse rate, respiration rate, temperature and pulse oximetry), resting 12-lead electrocardiogram (ECG), clinical laboratory tests and concomitant medication within 28 days prior to receiving study drug. On Day 1: subjects will receive a single oral dose of Aptensio XR®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate HCl ER Capsules, 10 mg | Experimental | Methylphenidate Hydrochloride Extended Release Capsules, 10 mg. Active drug, administered once |
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| Methylphenidate HCl ER Capsules, 15 mg | Experimental | Methylphenidate Hydrochloride Extended Release Capsules, 15 mg. Active drug, administered once |
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| Methylphenidate HCl ER Capsules, 20 mg | Experimental | Methylphenidate Hydrochloride Extended Release Capsules, 20 mg. Active drug, administered once |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylphenidate HCl ER Capsules, 10 mg | Drug | Methylphenidate Hydrochloride Extended-Release Capsules, 10 mg administered once daily in the morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum plasma concentration | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
| AUC(0-t) | Area under the plasma concentration versus time curve (calculated to the last measurable observation). AUC: Area Under the Curve | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
| AUC(0-inf) | Area under the plasma concentration versus time curve, extrapolated to infinity. AUC: Area Under the Curve | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
| AUC/D | Dose-normalized AUC0-t. AUC: Area Under the Curve | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
| CL/F | Apparent clearance. CL: Clearance | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
| V(Dss)/F | Volume of distribution | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
| Cmax/Dose | Dose-normalized Cmax | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax | Time to peak plasma concentration | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
| T1/2 | Elimination half-life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Akwete Adjei, Ph.D. | Rhodes Pharmaceuticals, L.P. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qps-Mra, Llc | South Miami | Florida | 33143 | United States | ||
| Duke Psychiatry and Behavioral Sciences, Duke University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32776159 | Derived | Adjei AL, Chaudhary I, Kollins SH, Padilla A. A Pharmacokinetic Study of Methylphenidate Hydrochloride Multilayer Extended-Release Capsules (Aptensio XR(R)) in Preschool-Aged Children with Attention-Deficit/Hyperactivity Disorder. Paediatr Drugs. 2020 Oct;22(5):561-570. doi: 10.1007/s40272-020-00409-z. |
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It was a parallel design study, where subjects were recruited from July 02, 2016 - July 19, 2017. Eligible subjects received one capsule of Methylphenidate HCl ER (10, 15, 20, 30, or 40 mg) on only one of the 3 dosing days depending on number of subjects recruited up each particular dosing day. Only 1 site was able to recruit subjects.
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylphenidate HCl ER 10 mg | Subjects received a single dose of Methylphenidate HCl ER 10 mg . This dose was equivalent to their current total daily methylphenidate dose. |
| FG001 | Methylphenidate HCl ER 15 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 13, 2018 |
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Open-label, single-dose
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| Methylphenidate HCl ER Capsules, 15 mg | Drug | Methylphenidate Hydrochloride Extended-Release Capsules, 15 mg administered once daily in the morning |
|
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| Methylphenidate HCl ER Capsules, 20 mg | Drug | Methylphenidate Hydrochloride Extended-Release Capsules, 20 mg administered once daily in the morning |
|
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| Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
| Kel | Terminal elimination constant | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
| Durham |
| North Carolina |
| 27705 |
| United States |
Subjects received a single dose of Methylphenidate HCl ER 15 mg . This dose was equivalent to their current total daily methylphenidate dose.
| FG002 | Methylphenidate HCl ER 20 mg | Subjects received a single dose of Methylphenidate HCl ER 20 mg . This dose was equivalent to their current total daily methylphenidate dose. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylphenidate HCl ER 10 mg | Subjects received a single dose of Methylphenidate HCl ER 10 mg |
| BG001 | Methylphenidate HCl ER 15 mg | Subjects received a single dose of Methylphenidate HCl ER 15 mg |
| BG002 | Methylphenidate HCl ER 20 mg | Subjects received a single dose of Methylphenidate HCl ER 20 mg |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| 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 | Cmax | Maximum plasma concentration | Per protocol | Posted | Mean | Standard Deviation | ng/mL | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
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| Primary | AUC(0-t) | Area under the plasma concentration versus time curve (calculated to the last measurable observation). AUC: Area Under the Curve | Per Protocol | Posted | Mean | Standard Deviation | ng*hr/mL | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
| |||||||||||||||||||||||||||||||||
| Primary | AUC(0-inf) | Area under the plasma concentration versus time curve, extrapolated to infinity. AUC: Area Under the Curve | Per protocol. (n=1) Standard Deviation was not estimable. | Posted | Mean | Standard Deviation | ng*hr/mL | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
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| Primary | AUC/D | Dose-normalized AUC0-t. AUC: Area Under the Curve | Per Protocol. | Posted | Mean | Standard Deviation | ng*hr/mL/mg | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
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| Primary | CL/F | Apparent clearance. CL: Clearance | Per protocol. (n=1) Standard Deviation was not estimable. | Posted | Mean | Standard Deviation | L/h | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
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| Primary | V(Dss)/F | Volume of distribution | Per protocol. (n=1) Standard Deviation was not estimable. | Posted | Mean | Standard Deviation | L | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
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| Primary | Cmax/Dose | Dose-normalized Cmax | Per Protocol | Posted | Mean | Standard Deviation | ng/mL/mg | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
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| Secondary | Tmax | Time to peak plasma concentration | Per Protocol | Posted | Median | Full Range | h | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
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| Secondary | T1/2 | Elimination half-life | Per Protocol. (n=1) Standard Deviation was not estimable. | Posted | Mean | Standard Deviation | h | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
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| Secondary | Kel | Terminal elimination constant | Per Protocol. (n=1) Standard Deviation was not estimable | Posted | Mean | Standard Deviation | h-1 | Day 1 at time 0 (within 30-60 minutes pre-dose) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post-dose |
|
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From check in until 24 hours post dose
Definitions for SAEs and AEs do not differ from ClinicalTrials.gov definitions
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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 | Methylphenidate HCl ER 10 mg | Subjects received a single dose of Methylphenidate HCl ER 10 mg | 0 | 5 | 0 | 5 | 1 | 5 |
| EG001 | Methylphenidate HCl ER 15 mg | Subjects received a single dose of Methylphenidate HCl ER 15 mg | 0 | 3 | 0 | 3 | 0 | 3 |
| EG002 | Methylphenidate HCl ER 20 mg | Subjects received a single dose of Methylphenidate HCl ER 20 mg | 0 | 2 | 0 | 2 | 0 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment | Not Related to study drug |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Akwete Adjei | Rhodes Pharmaceuticals L.P. | 401-262-9408 | akwete.adjei@rhodespharma.com |
| Sep 21, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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