Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacokinetic Study of Methylphenidate HCl Extended-Release Capsules in Children 4 to Under 6 Years of Age With ADHD (PK003)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02470234
Recruitment Status : Unknown
Verified February 2016 by Rhodes Pharmaceuticals, L.P..
Recruitment status was:  Recruiting
First Posted : June 12, 2015
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
Rhodes Pharmaceuticals, L.P.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Attention-Deficit/Hyperactivity Disorder Drug: Methylphenidate HCl ER Capsules Phase 4

Detailed Description:

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®.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pharmacokinetic Study of Aptensio XR® (Methylphenidate Hydrochloride Extended-release) Capsules in Male or Female Pre-School Children 4 to Under 6 Years of Age With ADHD in Fed Condition
Study Start Date : February 2016
Estimated Primary Completion Date : April 2016
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Methylphenidate HCl ER Capsules
Active drug, administered once
Drug: Methylphenidate HCl ER Capsules
Methylphenidate Hydrochloride Extended-Release Capsules administered once daily in the morning
Other Name: Aptensio XR®




Primary Outcome Measures :
  1. Cmax [ Time Frame: 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 ]
    Maximum plasma concentration

  2. AUC(0-t) [ Time Frame: 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 ]
    Area under the plasma concentration versus time curve (calculated to the last measurable observation)

  3. AUC(0-inf) [ Time Frame: 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 ]
    Area under the plasma concentration versus time curve, extrapolated to infinity

  4. AUC/D [ Time Frame: 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 ]
    Dose-normalized AUC

  5. CL/F [ Time Frame: 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 ]
    Apparent clearance

  6. V(dss)/F [ Time Frame: 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 ]
    Volume of distribution

  7. Cmax/dose [ Time Frame: 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 ]
    Dose-normalized Cmax


Secondary Outcome Measures :
  1. Tmax [ Time Frame: 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 ]
    Time to peak plasma concentration

  2. T1/2 [ Time Frame: 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 ]
    Elimination half-life

  3. Elimination rate constant (Kel) [ Time Frame: 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 ]
    Terminal elimination constant



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient is a male or female between the ages of 4 and under 6 years old.
  2. Patient has a history consistent with ADHD, meets the DSM-IV criteria for ADHD, inattentive, hyperactivity or combined.
  3. Patient must meet criteria for ADHD diagnosis on KSADS-PL and clinical interview by experienced clinician; symptoms must have been present for at least 6 months.
  4. Subject has had prior behavioral treatment or subject's symptoms are severe enough to warrant treatment without prior behavioral treatment, and patient is on a stable dose of either immediate-release or extended-release methylphenidate.
  5. Subject must have age- and sex-adjusted ratings of ≥ 90th percentile Total Score on the ADHD-RS-IV Preschool Version, a Clinical Global Impressions -Severity Score of ≥4 and a Child Global Assessment Scale rating of <65 after methylphenidate washout and prior to obtaining pharmacokinetic samples. Ratings may be completed via telephone on day-1.
  6. Parents or guardians of patients must have the ability to read and understand the language in which the Informed Consent is written and are mentally and physically competent to provide written informed consents for their child.
  7. Patient and/or parent are/is able to understand English in order to provide assent and is otherwise able to comply with the study protocol.

Exclusion Criteria:

  1. Patient has allergy to methylphenidate or amphetamines, or history of serious adverse reaction to methylphenidate.
  2. Patient has a history of tension, agitation, glaucoma, thyrotoxicosis, tachyarrythmias or severe angina pectoris or patient with serious or unstable medical illness such as asthma, diabetes or seizures.
  3. A history of motor or vocal tics or Tourette's syndrome
  4. Patient is receiving MAO inhibitors, anticonvulsants (phenobarbital, phenytoin, primidone), coumarin anticoagulants, presser agents, guanethidine, tricyclic antidepressants (imipramine, desipramine, selective serotonin inhibitors (SSRIs), or herbal remedies (e.g., melatonin).
  5. Patient has serious hypertension.
  6. Patient has a history of disorders of the sensory organs, particularly deafness, severe or profound retardation.
  7. Patient has any other unstable psychiatric condition requiring treatment.
  8. Patient is at risk for substance abuse.
  9. Evidence of current physical, sexual, or emotional abuse
  10. Living with anyone who currently abuses stimulants or cocaine
  11. History of bipolar disorder in both biological parents

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02470234


Contacts
Layout table for location contacts
Contact: Akwete Adjei, Ph.D. 401-262-9408 Akwete.Adjei@pharma.com

Locations
Layout table for location information
United States, Florida
Qps-Mra, Llc Recruiting
South Miami, Florida, United States, 33143
Contact: Americo F. Padilla, MD    305-279-0015      
United States, North Carolina
Duke Psychiatry and Behavioral Sciences, Duke University School of Medicine Recruiting
Durham, North Carolina, United States, 27705
Contact: Scott Kollins, PhD    919-681-9185      
Sponsors and Collaborators
Rhodes Pharmaceuticals, L.P.
Investigators
Layout table for investigator information
Study Director: Akwete Adjei, Ph.D. Rhodes Pharmaceuticals, L.P.

Layout table for additonal information
Responsible Party: Rhodes Pharmaceuticals, L.P.
ClinicalTrials.gov Identifier: NCT02470234     History of Changes
Other Study ID Numbers: RP-BP-PK003
First Posted: June 12, 2015    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Rhodes Pharmaceuticals, L.P.:
ADHD
Children
Pharmacokinetics
Additional relevant MeSH terms:
Layout table for MeSH terms
Methylphenidate
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents