Pharmacokinetics of HLD200 in Children and Adolescents With ADHD

NCT01907360 | Completed Phase 1 Results DMC

• 1 other identifier: HLD200-102
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention-Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (5)

• PK Parameters for Rate and Extent of Absorption of MPH: Lag Time

  The absorption lag time for methylphenidate in plasma expressed in hours is the difference in time between the drug administration and the last time point where the drug concentration was below the limit of assay quantitation.

  48hrs

• PK Parameters for Rate and Extent of Absorption of MPH: Cmax

  The maximum drug concentration of methylphenidate in plasma.

  48hrs

• PK Parameters for Rate and Extent of Absorption of MPH: Tmax

  The time to reach maximum concentration of methylphenidate in plasma.

  48hrs

• PK Parameters for Rate and Extent of Absorption of MPH: AUC0-tz

  Area under the methylphenidate plasma concentration-time curve to time point tz (AUC0-tz), where tz was the last time point over the time interval with a measurable drug concentration

  48hrs

• PK Parameters for Rate and Extent of Absorption of MPH: AUC0-inf

  The area under the methylphenidate plasma concentration-time curve to infinite time

  48hrs

Other Outcomes (1)

• PK Parameters for Rate and Extent of Absorption of MPH in Plasma: Plasma Concentration-time Curve

  48hrs

Study Arms (2)

HLD200 (methylphenidate hydrochloride) in Adolescents

EXPERIMENTAL

HLD200 (B formulation, 54 mg, oral capsules) administered as a single treatment in the evening to children aged 13-17 years.

Drug: HLD200 (methylphenidate hydrochloride)

HLD200 (methylphenidate hydrochloride) in Children

EXPERIMENTAL

HLD200 (B formulation, 54 mg, oral capsules) administered as a single treatment in the evening to children aged 6-12 years.

Drug: HLD200 (methylphenidate hydrochloride)

Interventions

HLD200 (methylphenidate hydrochloride) DRUG

Also known as: JORNAY PM

HLD200 (methylphenidate hydrochloride) in Adolescents; HLD200 (methylphenidate hydrochloride) in Children

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ironshore Pharmaceuticals and Development, Inc: lead

Study Sites (1)

Centre for Psychiatry & Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Related Publications (1)

• Childress A, Mehrotra S, Gobburu J, McLean A, DeSousa NJ, Incledon B. Single-Dose Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate Formulation, in Healthy Adults and in Adolescents and Children with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2018 Feb;28(1):10-18. doi: 10.1089/cap.2017.0044. Epub 2017 Oct 17.

  PMID: 29039979 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Scientific Officer
• Organization: Ironshore Pharmaceuticals and Development, Inc.

bev@ironshorepharma.com

13457498174

Study Officials

• Ann Childress, M.D.

  Centre for Psychiatry & Behavioral Medicine, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label, single-treatment

Study Record Dates

• First Submitted: July 12, 2013
• First Posted: July 24, 2013
• Study Start: August 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 23, 2021
• Results First Posted: September 20, 2021

Record last verified: 2021-11

Locations

US (1)