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

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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.

Tracking Information
First Submitted Date  ICMJE June 3, 2015
First Posted Date  ICMJE June 12, 2015
Last Update Posted Date February 9, 2016
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2016)
  • 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
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: June 11, 2015)
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 ]
Peak plasma concentration
Change History Complete list of historical versions of study NCT02470234 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2015)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacokinetic Study of Methylphenidate HCl Extended-Release Capsules in Children 4 to Under 6 Years of Age With ADHD
Official Title  ICMJE 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
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.
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®.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Attention-Deficit/Hyperactivity Disorder
Intervention  ICMJE Drug: Methylphenidate HCl ER Capsules
Methylphenidate Hydrochloride Extended-Release Capsules administered once daily in the morning
Other Name: Aptensio XR®
Study Arms  ICMJE Experimental: Methylphenidate HCl ER Capsules
Active drug, administered once
Intervention: Drug: Methylphenidate HCl ER Capsules
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 11, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2016
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02470234
Other Study ID Numbers  ICMJE RP-BP-PK003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rhodes Pharmaceuticals, L.P.
Study Sponsor  ICMJE Rhodes Pharmaceuticals, L.P.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Akwete Adjei, Ph.D. Rhodes Pharmaceuticals, L.P.
PRS Account Rhodes Pharmaceuticals, L.P.
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP