A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to \<13 years with CNS disorders.
A US based nonrandomized, sequential cohort, crossover trial to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to \<13 years with CNS disorders who are receiving antipsychotic treatment for their medical condition.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Tablet
Woodland International Research Group
Little Rock, Arkansas, United States
Woodland Research Northwest, LLC
Rogers, Arkansas, United States
Alliance for Wellness dba Alliance for Research
Long Beach, California, United States
Maximum Plasma Concentration (Cmax) [PK]
The maximum plasma concentration of drug will be assessed for brexpiprazole and its major metabolite DM-3411.
Time frame: Up to 22 days or early termination
Area under concentration-time curve (AUC) calculated from time zero to time t (AUCt) [PK]
AUCt will be assessed for plasma brexpiprazole and its major metabolite DM-3411 to determine average concentration of drug over time
Time frame: Up to 22 days or early termination
AUC from time zero to infinity [PK]
AUC infinity will be assessed for plasma brexpiprazole and its major metabolite DM-3411 to determine total drug exposure over time
Time frame: Up to 22 days or early termination
Time of maximum plasma concentration (tmax) [PK]
The amount of time that the maximum plasma concentration of drug will be assessed for plasma brexpiprazole and its major metabolite DM-3411
Time frame: Up to 22 days or early termination
Terminal-phase elimination half-life (t½,z) [PK]
t½,z will be assessed for plasma brexpiprazole and its major metabolite DM-3411 to determine drug persistence in the body
Time frame: Up to 22 days or early termination
Apparent clearance of drug from plasma after extravascular administration (CL/F) [PK]
CL/F for brexpiprazole only
Time frame: Up to 22 days or early termination
Treatment-Emergent Adverse Events (TEAES) [Safety]
Time frame: Up to 22 days or early termination with a 21 day follow-up period
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New Hope Clinical Research
Charlotte, North Carolina, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States
Road Runner Research Ltd.
San Antonio, Texas, United States
Aspen Clinical Research
Orem, Utah, United States
Clinical laboratory tests [Safety]
Collect hematology, serum chemistry,and urinalysis will be assessed to determine the safety and tolerability of drug
Time frame: Up to 22 days or early termination
Vital signs observed and change from baseline data (systolic and diastolic blood pressure) [Safety]
Time frame: Up to 22 days or early termination
Vital signs observed and change from baseline data (heart rate) [Safety]
Time frame: Up to 22 days or early termination
Vital signs observed and change from baseline data (respiratory rate) [Safety]
Time frame: Up to 22 days or early termination
Vital signs observed and change from baseline data (body temperature) [Safety]
Time frame: Up to 22 days or early termination
12-lead electrocardiogram (ECGs) [Safety]
Time frame: Up to 22 days or early termination
Physical examinations (height) [Safety]
Height is measured in cm,and will be used to calculate Body Mass Index (BMI)
Time frame: Up to 22 days or early termination
Physical examinations (weight) [Safety]
Weight is measured in kg, and will be used to calculate Body Mass Index (BMI)
Time frame: Up to 22 days or early termination
Physical examinations- Body Mass Index (BMI) [Safety]
Body Mass Index (BMI) measured using height (cm) and weight (kg)
Time frame: Up to 22 days or early termination
Physical examinations- review of body systems [Safety]
Subject will be examined by site staff for any notable changes
Time frame: Up to 22 days or early termination
Simpson-Angus Scale (SAS) rating scale [Safety]
Will be used in analysis of Extrapyramidal Symptoms (EPS)
Time frame: Up to 22 days or early termination
Abnormal Involuntary Movement Scale (AIMS) [Safety]
Will be used in analysis of Extrapyramidal Symptoms (EPS)
Time frame: Up to 22 days or early termination
Barnes Akathisia Rating Scale (BARS) [Safety]
Will be used in analysis of Extrapyramidal Symptoms (EPS)
Time frame: Up to 22 days or early termination
Columbia-Suicide Severity Rating Scale (C-SSRS) [Safety]
Time frame: Up to 22 days or early termination