Pharmacokinetics of HLD200 in Children and Adolescents With ADHD

• Status: Completed
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to assess the pharmacokinetic effects of a single dose of HLD200 (methylphenidate hydrochloride) in children and adolescents with ADHD.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ironshore Pharmaceuticals and Development, Inc
• Treatments: Methylphenidate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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).