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

NCT02578030 | Completed Phase 1

• 1 other identifier: SHP465-111
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (14)

• Maximum Observed Drug Concentration (Cmax) of Dextroamphetamine (d-amphetamine) in Plasma

  Maximum concentration occurring at time of maximum observed concentration of d-amphetamine during a dosing interval.

  Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose

• Maximum Observed Drug Concentration (Cmax) for Levoamphetamine (l-amphetamine) in Plasma

  Maximum observed concentration of l-amphetamine during a dosing interval.

  Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose

• Time to Reach Maximum Observed Drug Concentration (Tmax) of Dextroamphetamine (d-amphetamine) in Plasma

  Time to reach maximum observed drug concentration of d-amphetamine during a dosing interval.

  Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose

• Time to Reach Maximum Observed Drug Concentration (Tmax) of Levoamphetamine (l-amphetamine) in Plasma

  Time to reach maximum observed drug concentration of l-amphetamine during a dosing interval.

  Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose

• Area Under the Curve From Zero to Infinity (AUC0-infinity) of Dextroamphetamine (d-amphetamine) in Plasma

  AUC0-infinity was calculated using the observed value of the last non-zero concentration of d-amphetamine in plasma.

  Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose

• Area Under the Curve From Zero to Infinity (AUC0-infinity) of Levoamphetamine (l-amphetamine) in Plasma

  AUC0-infinity was calculated using the observed value of the last non-zero concentration of l-amphetamine in plasma.

  Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose

• Area Under the Curve From Zero to Last Measurable Concentration (AUClast) of Dextroamphetamine (d-amphetamine) in Plasma

  Area under the curve from the time of dosing to the last measurable concentration of d-amphetamine in plasma.

  Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose

• Area Under the Curve From Zero to Last Measurable Concentration (AUClast) of Levoamphetamine (l-amphetamine) in Plasma

  Area under the curve from the time of dosing to the last measurable concentration of l-amphetamine in plasma.

  Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose

• Terminal Half-life (t½) of Dextramphetamine (d-amphetamine) in Plasma

  Terminal half-life is the time measured for the plasma concentration of d-amphetamine to decrease by one half.

  Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose

• Terminal Half-life (t½) of Levoamphetamine (l-amphetamine) in Plasma

  Terminal half-life is the time measured for the plasma concentration of l-amphetamine to decrease by one half.

  Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose

• Total Body Clearance for Extravascular Administration (CL/F) of Dextroamphetamine (d-amphetamine)

  Total body clearance for extravascular administration of d-amphetamine divided by the fraction of dose absorbed.

  Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose

• Total Body Clearance for Extravascular Administration (CL/F) of Levoamphetamine (l-amphetamine)

  Total body clearance for extravascular administration of l-amphetamine divided by the fraction of dose absorbed.

  Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose

• Volume of Distribution After Extravascular Administration (Vz/F) of Dextroamphetamine (d-amphetamine)

  Volume of distribution for d-amphetamine based on the terminal phase following extravascular administration divided by the fraction of dose absorbed.

  Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose

• Volume of Distribution After Extravascular Administration (Vz/F) of Levoamphetamine (l-amphetamine)

  Volume of distribution for l-amphetamine based on the terminal phase following extravascular administration divided by the fraction of dose absorbed.

  Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose

Secondary Outcomes (3)

• Participants with Treatment-emergent Adverse Events (TEAEs)

  From start of study drug administration up to follow-up (up to 9 days)

• Number of Participants With TEAE Related to Vital signs, Electrocardiogram (ECG), and Clinical Laboratory Tests

  From start of study drug administration up to follow-up (up to 9 days)

• Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS)

  Baseline up to Day 4

Study Arms (2)

SHP465 12.5 mg

EXPERIMENTAL

A single dose of SHP465 12.5 mg for Subjects aged 6-12 years

Drug: SHP465 12.5mg

SHP465 25 mg

EXPERIMENTAL

A single dose of SHP465 25 mg for Subjects aged 13-17 years

Drug: SHP465 25mg

Interventions

SHP465 12.5mg DRUG

SHP465 12.5 mg

SHP465 25mg DRUG

SHP465 25 mg

Eligibility Criteria

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

You may qualify if:

• 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'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

Sponsors & Collaborators

• Shire: lead

Study Sites (3)

QPS MRA

Miami, Florida, 33143, United States

Location

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

Houston Clinical Research

Houston, Texas, 77098, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: October 16, 2015
• Study Start: October 24, 2015
• Primary Completion: November 10, 2015
• Study Completion: November 10, 2015
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

US (3)