Clinical trial NCT02578030: Pharmacokinetic Study in Children and Adolescents Aged 6 to 17 Years Who Have Been Diagnosed With ADHD
Official title: A Phase 1, Open-label Study of the Pharmacokinetics of d- and L-amphetamine After a Single Dose of SHP465 12.5 mg or 25 mg Administered to Children and Adolescents Aged 6 to17 Years With Attention-Deficit Hyperactivity Disorder (ADHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2015-10-16
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. 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.
2. 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.
3. 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.
4. Subject is functioning at an age appropriate level intellectually, as determined by the investigator.
5. 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.
6. Ability to swallow a capsule of investigational product whole.

Exclusion Criteria:

1. Current use of any ADHD medication other than an amphetamine-based product.
2. History of any hematological, hepatic, respiratory, cardiovascular, renal, neurological or psychiatric disease, gall bladder removal, or current or recurrent disease other than their ADHD
3. Current or relevant history of physical or psychiatric illness, any medical disorder that may require treatment
4. Subject has a current, controlled or uncontrolled, comorbid psychiatric diagnosis with significant symptoms
5. Subject meets DSM-V diagnosis of conduct disorder.
6. 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.
7. Subject is underweight based on Centers for Disease Control and Prevention (CDC) body mass index (BMI)- for-age sex-specific values
8. Subject is significantly overweight based on CDC BMI-for-age sex specific values
9. 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
10. Subject has a concurrent chronic or acute illness, disability, or other condition that might confound the results of safety assessments conducted in the study
11. 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.
12. Subject's blood pressure measurements exceed the 90th percentile for age, sex, and height
13. Subject has a known history of hypertension.
14. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
15. Subject has any clinically significant ECG or clinically significant laboratory abnormality
16. Subject has abnormal thyroid function
17. Known or suspected intolerance or hypersensitivity to the investigational product(s), closely-related compounds, or any ingredients.
18. 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.
19. 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
20. A positive screen for alcohol or drugs of abuse. A positive hepatitis B surface antigen (HBsAg); hepatitis C virus (HCV); or HIV antibody screen.
21. Use of tobacco in any form in the last 30 days
22. Prior screen failure, enrollment, or participation in this study.

Primary outcomes:
measure: Maximum Observed Drug Concentration (Cmax) of Dextroamphetamine (d-amphetamine) in Plasma
timeFrame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
measure: Maximum Observed Drug Concentration (Cmax) for Levoamphetamine (l-amphetamine) in Plasma
timeFrame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
measure: Time to Reach Maximum Observed Drug Concentration (Tmax) of Dextroamphetamine (d-amphetamine) in Plasma
timeFrame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
measure: Time to Reach Maximum Observed Drug Concentration (Tmax) of Levoamphetamine (l-amphetamine) in Plasma
timeFrame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
measure: Area Under the Curve From Zero to Infinity (AUC0-infinity) of Dextroamphetamine (d-amphetamine) in Plasma
timeFrame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
measure: Area Under the Curve From Zero to Infinity (AUC0-infinity) of Levoamphetamine (l-amphetamine) in Plasma
timeFrame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
measure: Area Under the Curve From Zero to Last Measurable Concentration (AUClast) of Dextroamphetamine (d-amphetamine) in Plasma
timeFrame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
measure: Area Under the Curve From Zero to Last Measurable Concentration (AUClast) of Levoamphetamine (l-amphetamine) in Plasma
timeFrame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
measure: Terminal Half-life (t½) of Dextramphetamine (d-amphetamine) in Plasma
timeFrame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
measure: Terminal Half-life (t½) of Levoamphetamine (l-amphetamine) in Plasma
timeFrame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
measure: Total Body Clearance for Extravascular Administration (CL/F) of Dextroamphetamine (d-amphetamine)
timeFrame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
measure: Total Body Clearance for Extravascular Administration (CL/F) of Levoamphetamine (l-amphetamine)
timeFrame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
measure: Volume of Distribution After Extravascular Administration (Vz/F) of Dextroamphetamine (d-amphetamine)
timeFrame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
measure: Volume of Distribution After Extravascular Administration (Vz/F) of Levoamphetamine (l-amphetamine)
timeFrame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Secondary outcomes:
measure: Participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: From start of study drug administration up to follow-up (up to 9 days)
measure: Number of Participants With TEAE Related to Vital signs, Electrocardiogram (ECG), and Clinical Laboratory Tests
timeFrame: From start of study drug administration up to follow-up (up to 9 days)
measure: Number of Participants With Suicidal Behavior and / or Ideation ("Yes" Response) on the Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline up to Day 4
Other outcomes:
Locations:
city: Miami
country: United States
facility: QPS MRA
state: Florida
city: Las Vegas
country: United States
facility: Center for Psychiatry and Behavioral Medicine, Inc.
state: Nevada
city: Houston
country: United States
facility: Houston Clinical Research
state: Texas
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: