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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-dose, 2, 4, 6, 8, 10, 12, 24, 48, 72 hours post-dose
Participants with Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An AE was considered as treatment-emergent (TEAE) if it had a start date and time on or after the dose of investigational product and no later than 72 hours after dosing, or if it had a start date and time before the date and time of the dose of investigational product, but increased in severity on or after the date and time of the dose of investigational product and no later than 72 hours after dosing.
Time frame: 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
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Vital signs included blood pressure, pulse rate, respiratory rate, and body temperature. ECG was analysed as 12-lead ECG. Clinical laboratory test is considered for biochemistry, Hematology and Urinalysis.
Time frame: 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)
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).
Time frame: Baseline up to Day 4