Pharmacokinetic Study in Children and Adolescents Aged 6 to 17 Years Who Have Been Diagnosed With ADHD

Completed · Phase 1

Conditions studied: Attention Deficit Hyperactivity Disorder (ADHD)

In brief

To provide additional, required information on the pharmacokinetic profile of SHP465 in the targeted population (children and adolescents aged 6-17 years of age with ADHD).

Key facts

Study ID

NCT02578030

Run by

Shire

People needed

27

Starts

2015-10-24

Expected to finish

2015-11-10

Last updated by the study team

2021-05-18

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 6 to 17 years inclusive at the time of consent/assent. The date of signature of the informed consent/assent is defined as the beginning of the Screening Period. This inclusion criterion will only be assessed at the first screening visit.
• Male, or non-pregnant, non-lactating female who agrees to comply with any applicable contraceptive requirements of the protocol or females of non-childbearing potential.
• Subject meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for a primary diagnosis of ADHD based on an accepted ADHD diagnostic instrument and documented in the subject's medical record. Subject's ADHD is currently adequately controlled with an amphetamine-based product.
• Subject is functioning at an age appropriate level intellectually, as determined by the investigator.
• Must be considered "healthy". Healthy status is defined by absence of evidence of any active or chronic disease other than their ADHD following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, hematology, blood chemistry, and urinalysis.
• Ability to swallow a capsule of investigational product whole.

You may not qualify if…

• Current use of any ADHD medication other than an amphetamine-based product.
• History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current or recurrent disease other than their ADHD
• Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment
• Subject has a current, controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms
• Subject meets DSM-V diagnosis of conduct disorder.
• Subject is considered a suicide risk in the opinion of the investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation.
• Subject is underweight based on Centers for Disease Control and Prevention (CDC) body mass index (BMI)- for-age sex-specific values
• Subject is significantly overweight based on CDC BMI-for-age sex specific values
• Subject has a known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems
• Subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments conducted in the study
• Subject has a history of seizure, a chronic or current tic disorder, or a current diagnosis of Tourette's Disorder. Subject has a history of tics that are judged to be exclusionary.
• Subject's blood pressure measurements exceed the 90th percentile for age, sex, and height
• Subject has a known history of hypertension.
• Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
• Subject has any clinically significant ECG or clinically significant laboratory abnormality
• Subject has abnormal thyroid function
• Known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any ingredients.
• History of alcohol or other substance abuse within the last year. Subjects with a lifetime history of amphetamine, cocaine, or other stimulant abuse and/or dependence will be excluded.
• Use Within 30 days prior to the first dose of investigational product:
• have used an investigational product
• have been enrolled in a clinical study (including vaccine)
• have had any substantial changes in eating habits
• A positive screen for alcohol or drugs of abuse. A positive hepatitis B surface antigen (HBsAg); hepatitis C virus (HCV); or HIV antibody screen.
• Use of tobacco in any form in the last 30 days
• Prior screen failure, enrollment, or participation in this study.

Where it is running

• QPS MRA — Miami, Florida, United States
• Center for Psychiatry and Behavioral Medicine, Inc. — Las Vegas, Nevada, United States
• Houston Clinical Research — Houston, Texas, United States

Full record on ClinicalTrials.gov

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