pharmacokinetics of hld200 in children and adolescents with adhd

Conditions: Attention-Deficit Hyperactivity Disorder

Summary: this study was designed to assess the pharmacokinetic effects of a single dose of hld200 (methylphenidate hydrochloride) in children and adolescents with adhd.

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 (13-17 years) with adhd. following a screening period that included five days washout to allow for clearance of any prior adhd medications, subjects were domiciled in-clinic and administered hld200 (b-formulation; 54 mg; oral capsule) at 9 pm under fasted conditions. subjects were then observed for safety and tolerability and a total of 18 blood samples collected during a 48 hour period (at t=0, 4, 6, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 22, 24, 36 and 48 hours post-dosing). these samples were then assayed for methylphenidate plasma concentrations and this data used for calculation of pharmacokinetic parameters.

Eligibility 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).