The purpose of this trial is to assess the safety, tolerability and pharmacokinetics of aripiprazole tablets following oral administration to children and adolescents.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Aripiprazole tablets ranging from 2 to 30 mg to be taken orally once a day.
Percentage of Participants Able to Tolerate Maximum Dose Level
Dose toleration was defined as the following: during the course of the study the participant does not experience any untoward events or potentially clinically significant changes from baseline in laboratory values, vital signs, electrocardiogram (ECG) tracings, or Extrapyramidal symptoms (EPS) ratings (evaluation of parkinsonism, dyskinesia, and akathisia) that are assessed as possibly related to the drug, and would warrant adjustment or discontinuation of the study drug.
Time frame: 14 Days
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuation Due to Adverse Event as a Measure of Safety
An adverse event was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events. A serious adverse event is any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Time frame: 57 days
Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
Blood samples were collected pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post dose on Day 14 and were analyzed by a validated High-Performance Liquid Chromatography/ Mass Spectrometry (HPLC-MS/MS) method for aripiprazole. Css,max value was determined using observed data.
Time frame: Pre-dose and 1 to 24 hours post-dose on Day 14
Aripiprazole Time to Maximum (Peak) Plasma Concentration (Tmax)
Blood samples were collected pre-dose and 1, 2, 3, 4, 6, 8, 10, 24 and 25 hours post dose on Day 14 and were analyzed by a validated High-Performance Liquid Chromatography/ Mass Spectrometry (HPLC-MS/MS) method for aripiprazole. Tmax value was determined using observed data.
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Time frame: Pre-dose and 1 to 25 hours post-dose on Day 14
Aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ)
Blood samples were collected pre-dose and 1, 2, 3, 4, 6, 8, 10, and 24 hours post-dose on Day 14 and were analyzed by a validated High-Performance Liquid Chromatography/ Mass Spectrometry (HPLC-MS/MS) method for aripiprazole. Values of AUCτ were estimated using the linear trapezoidal rule to the actual time of the 24-hour sample.
Time frame: Pre-dose and 1 to 24 hours post-dose on Day 14
Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) at Day 1 and Day 14
The severity of illness for each participant was rated using the CGI-S scale. The investigator answered the following question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" using an 8-point scale where 0=not assessed, 1=normal, not at all ill; to 7=among the most extremely ill patients. A negative change from Baseline indicated improvement.
Time frame: Baseline, Day 1, Day 14
Clinical Global Impression Scale-Improvement (CGI-I) Score at Day 1 and Day 14
The participant's overall improvement was rated for each participant using the CGI-I scale. The investigator rated the participant's total improvement by answering the following question: "Compared to his/her condition at baseline (prior to randomization), how much has the patient changed?" using an 8-point scale where 0=not assessed, 1=very much improved to 7=very much worse. Lower scores indicated improvement.
Time frame: Days 1 and 14