Status:
COMPLETED
Pharmacokinetics of HLD200 in Children and Adolescents With ADHD
Lead Sponsor:
Ironshore Pharmaceuticals and Development, Inc
Conditions:
Attention-Deficit Hyperactivity Disorder
Eligibility:
All Genders
6-17 years
Phase:
PHASE1
PHASE2
Brief Summary
This study was designed to assess the pharmacokinetic effects of a single dose of HLD200 (methylphenidate hydrochloride) in children and adolescents with ADHD.
Detailed Description
This study utilized a single-center, open-label, single-treatment, fasted design to examine the rate and extent of absorption of evening-administered HLD200 in children (6-12 years) and adolescents (1...
Eligibility Criteria
Inclusion
- Male and female adolescents (13-17 years) and children (6-12 years).
- Previous diagnosis of ADHD and confirmation using the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
- ADHD symptoms controlled on a stable dose of ADHD medication. Subjects should be on MPH or have previous history of symptom control during treatment with MPH.
- Physical examination free of clinically significant findings, unless deemed NCS by the Investigator and Medical Monitor;
- Able to swallow treatment capsules;
- Available for entire study period;
- Provision of informed consent (from the parent\[s\] and/or legal representative\[s\]) and assent (from the subject); and
- Female subjects of childbearing potential (i.e., post-menarche) required to have a negative result on urine pregnancy testing (and will be given specific instructions on avoiding pregnancy during trial)
Exclusion
- Any known history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, ophthalmologic disease, unless deemed NCS by the Investigator and the Medical Monitor;
- Presence of any significant physical or organ abnormality;
- Any illness during the 4 weeks before this study, unless deemed NCS by the Investigator and the Clinical and/or Medical Monitor;
- Severe comorbid psychiatric diagnosis that may affect subject safety or confound results (e.g., psychosis, bipolar disorder);
- Known history of moderate to severe asthma;
- Known history of severe allergic reaction (including drugs, food, insect bites, environmental allergens);
- Known history of seizures (except febrile seizures prior to age 5), anorexia nervosa, bulimia or current diagnosis or family history of Tourette's disorder;
- Subject who are severely underweight or overweight.
- Clinical value outside of the acceptable ranges, unless deemed NCS significant per the Investigator;
- Positive history for hepatitis B, hepatitis C and Human Immunodeficiency Virus (HIV);
- Positive screening for illicit drug use, and/or current health conditions or use of medications that might confound the results of the study or increase risk to the subject;
- Use of prescription medications (except ADHD medications) within 7 days and over-the counter medications (except birth control) within the 3 days preceding study enrollment, unless deemed acceptable by the Investigator and Clinical and/or Medical Monitor;
- Blood draws of 50 ml to 249 ml within the 30 days, 250 ml to 449 ml within the 45 days and ≥ 450 ml within the 60 days preceding study enrollment;
- Participation in clinical trial with an investigational drug within the 30 days preceding study enrollment;
- Intolerance to venipuncture; and
- Current suicidal ideation or history of suicidality determined as a significant finding on the Columbia-Suicide Severity Rating Scale (C-SSRS) by the investigator (Baseline C-SSRS for adolescents; Pediatric Baseline C-SSRS for children).
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01907360
Start Date
August 1 2013
End Date
October 1 2013
Last Update
December 23 2021
Active Locations (1)
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1
Centre for Psychiatry & Behavioral Medicine, Inc.
Las Vegas, Nevada, United States, 89128