Trial Outcomes & Findings for Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents (NCT NCT00102479)
NCT ID: NCT00102479
Last Updated: 2026-06-22
Results Overview
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.
COMPLETED
PHASE1
21 participants
Pre-dose and 1 to 25 hours post-dose on Day 14
2026-06-22
Participant Flow
Participant milestones
| Measure |
Aripiprazole 20 mg
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 20 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 20 mg for 14 days.
|
Aripiprazole 25 mg
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 25 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 25 mg for 14 days.
|
Aripiprazole 30 mg
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 30 mg. Following the dose-escalation phase, participants entered the fixed-dose phase and received 30 mg for 14 days.
|
|---|---|---|---|
|
Dose-escalation Phase
STARTED
|
8
|
7
|
6
|
|
Dose-escalation Phase
COMPLETED
|
8
|
7
|
6
|
|
Dose-escalation Phase
NOT COMPLETED
|
0
|
0
|
0
|
|
Between Phases
STARTED
|
8
|
7
|
6
|
|
Between Phases
COMPLETED
|
7
|
6
|
6
|
|
Between Phases
NOT COMPLETED
|
1
|
1
|
0
|
|
Fixed-dose Phase
STARTED
|
7
|
6
|
6
|
|
Fixed-dose Phase
COMPLETED
|
6
|
5
|
6
|
|
Fixed-dose Phase
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Aripiprazole 20 mg
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 20 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 20 mg for 14 days.
|
Aripiprazole 25 mg
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 25 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 25 mg for 14 days.
|
Aripiprazole 30 mg
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 30 mg. Following the dose-escalation phase, participants entered the fixed-dose phase and received 30 mg for 14 days.
|
|---|---|---|---|
|
Between Phases
Withdrawal by Subject
|
1
|
1
|
0
|
|
Fixed-dose Phase
Protocol Violation
|
1
|
0
|
0
|
|
Fixed-dose Phase
Adverse Event
|
0
|
1
|
0
|
Baseline Characteristics
Aripiprazole Pharmacokinetics (PK) and Tolerability Study in Children and Adolescents
Baseline characteristics by cohort
| Measure |
Aripiprazole 20 mg
n=8 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 20 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 20 mg for 14 days.
|
Aripiprazole 25 mg
n=7 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 25 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 25 mg for 14 days.
|
Aripiprazole 30 mg
n=6 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 30 mg. Following the dose-escalation phase, participants entered the fixed-dose phase and received 30 mg for 14 days.
|
Total
n=21 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
12.4 years
STANDARD_DEVIATION 2.5 • n=20 Participants
|
13.3 years
STANDARD_DEVIATION 1.8 • n=20 Participants
|
10.8 years
STANDARD_DEVIATION 1.2 • n=40 Participants
|
12.2 years
STANDARD_DEVIATION 2.1 • n=6 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
7 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
14 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: 14 DaysPopulation: All enrolled participants who received study drug and who had a baseline and a post-baseline score for CGI-Severity or a post-baseline score for CGI Improvement were included in the efficacy analysis.
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.
Outcome measures
| Measure |
Aripiprazole 20 mg
n=6 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 20 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 20 mg for 14 days.
|
Aripiprazole 25 mg
n=5 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 25 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 25 mg for 14 days.
|
Aripiprazole 30 mg
n=6 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 30 mg. Following the dose-escalation phase, participants entered the fixed-dose phase and received 30 mg for 14 days.
|
|---|---|---|---|
|
Percentage of Participants Able to Tolerate Maximum Dose Level
|
83 Percentage of Participants
|
80 Percentage of Participants
|
100 Percentage of Participants
|
PRIMARY outcome
Timeframe: 57 daysPopulation: All participants who received at least one dose of study medication were included in the safety analysis.
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.
Outcome measures
| Measure |
Aripiprazole 20 mg
n=8 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 20 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 20 mg for 14 days.
|
Aripiprazole 25 mg
n=7 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 25 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 25 mg for 14 days.
|
Aripiprazole 30 mg
n=6 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 30 mg. Following the dose-escalation phase, participants entered the fixed-dose phase and received 30 mg for 14 days.
|
|---|---|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuation Due to Adverse Event as a Measure of Safety
Adverse Event
|
8 participants
|
7 participants
|
6 participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuation Due to Adverse Event as a Measure of Safety
Serious Adverse Event
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Discontinuation Due to Adverse Event as a Measure of Safety
Discontinued due to Adverse Event
|
0 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Pre-dose and 1 to 24 hours post-dose on Day 14Population: All enrolled participants who received study drug with viable pharmacokinetic measurements were included in the analysis.
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.
Outcome measures
| Measure |
Aripiprazole 20 mg
n=6 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 20 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 20 mg for 14 days.
|
Aripiprazole 25 mg
n=5 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 25 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 25 mg for 14 days.
|
Aripiprazole 30 mg
n=6 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 30 mg. Following the dose-escalation phase, participants entered the fixed-dose phase and received 30 mg for 14 days.
|
|---|---|---|---|
|
Aripiprazole Maximum Steady State Plasma Concentration (Css,Max)
|
435 ng/mL
Standard Deviation 137
|
529 ng/mL
Standard Deviation 341
|
653 ng/mL
Standard Deviation 213
|
PRIMARY outcome
Timeframe: Pre-dose and 1 to 25 hours post-dose on Day 14Population: All enrolled participants who received study drug with viable pharmacokinetic measurements were included in the analysis.
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.
Outcome measures
| Measure |
Aripiprazole 20 mg
n=6 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 20 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 20 mg for 14 days.
|
Aripiprazole 25 mg
n=5 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 25 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 25 mg for 14 days.
|
Aripiprazole 30 mg
n=6 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 30 mg. Following the dose-escalation phase, participants entered the fixed-dose phase and received 30 mg for 14 days.
|
|---|---|---|---|
|
Aripiprazole Time to Maximum (Peak) Plasma Concentration (Tmax)
|
2.00 hours
Interval 1.0 to 24.08
|
2.05 hours
Interval 1.0 to 4.02
|
2.00 hours
Interval 1.0 to 8.0
|
PRIMARY outcome
Timeframe: Pre-dose and 1 to 24 hours post-dose on Day 14Population: All enrolled participants who received study drug with viable pharmacokinetic measurements were included in the analysis.
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.
Outcome measures
| Measure |
Aripiprazole 20 mg
n=6 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 20 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 20 mg for 14 days.
|
Aripiprazole 25 mg
n=5 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 25 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 25 mg for 14 days.
|
Aripiprazole 30 mg
n=6 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 30 mg. Following the dose-escalation phase, participants entered the fixed-dose phase and received 30 mg for 14 days.
|
|---|---|---|---|
|
Aripiprazole Area Under the Concentration-Time Curve at Steady-State (AUCτ)
|
8031 ng⋅h/mL
Standard Deviation 3745
|
9488 ng⋅h/mL
Standard Deviation 7001
|
12770 ng⋅h/mL
Standard Deviation 5444
|
SECONDARY outcome
Timeframe: Baseline, Day 1, Day 14Population: All enrolled participants who received study drug with a post-baseline score, with Last Observation Carried Forward (LOCF).
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.
Outcome measures
| Measure |
Aripiprazole 20 mg
n=7 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 20 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 20 mg for 14 days.
|
Aripiprazole 25 mg
n=7 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 25 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 25 mg for 14 days.
|
Aripiprazole 30 mg
n=6 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 30 mg. Following the dose-escalation phase, participants entered the fixed-dose phase and received 30 mg for 14 days.
|
|---|---|---|---|
|
Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) at Day 1 and Day 14
Day 1
|
-0.86 units on a scale
Standard Deviation 0.90
|
-1.50 units on a scale
Standard Deviation 0.55
|
-2.00 units on a scale
Standard Deviation 0.63
|
|
Change From Baseline in Clinical Global Impression Scale-Severity (CGI-S) at Day 1 and Day 14
Day 14
|
-1.57 units on a scale
Standard Deviation 0.98
|
-1.43 units on a scale
Standard Deviation 1.13
|
-2.33 units on a scale
Standard Deviation 0.52
|
SECONDARY outcome
Timeframe: Days 1 and 14Population: All enrolled participants who received study medication with observed data at the categorical time point. Overall number analyzed is the number of participants with data available for analysis. Number analyzed are the number of participants with data available for analysis at the specified time-point.
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.
Outcome measures
| Measure |
Aripiprazole 20 mg
n=7 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 20 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 20 mg for 14 days.
|
Aripiprazole 25 mg
n=6 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 25 milligrams (mg). Following the dose-escalation phase, participants entered the fixed-dose phase and received 25 mg for 14 days.
|
Aripiprazole 30 mg
n=6 Participants
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 30 mg. Following the dose-escalation phase, participants entered the fixed-dose phase and received 30 mg for 14 days.
|
|---|---|---|---|
|
Clinical Global Impression Scale-Improvement (CGI-I) Score at Day 1 and Day 14
Day 1
|
2.29 units on a scale
Standard Deviation 0.76
|
1.83 units on a scale
Standard Deviation 0.41
|
1.33 units on a scale
Standard Deviation 0.52
|
|
Clinical Global Impression Scale-Improvement (CGI-I) Score at Day 1 and Day 14
Day 14
|
1.67 units on a scale
Standard Deviation 0.52
|
1.40 units on a scale
Standard Deviation 0.55
|
1.33 units on a scale
Standard Deviation 0.82
|
Adverse Events
Aripiprazole 20 mg
Aripiprazole 25 mg
Aripiprazole 30 mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Aripiprazole 20 mg
n=8 participants at risk
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 20 mg. Following the dose-escalation phase, participants entered the fixed-dose phase and received 20 mg for 14 days.
|
Aripiprazole 25 mg
n=7 participants at risk
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 25 mg. Following the dose-escalation phase, participants entered the fixed-dose phase and received 25 mg for 14 days.
|
Aripiprazole 30 mg
n=6 participants at risk
Participants were administered aripiprazole tablets to be taken orally once daily starting at a dose of 2 mg increased over 12 days to achieve a dose level of 30 mg. Following the dose-escalation phase, participants entered the fixed-dose phase and received 30 mg for 14 days.
|
|---|---|---|---|
|
Infections and infestations
Rhinitis
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/6
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/8
|
0.00%
0/7
|
16.7%
1/6
|
|
Investigations
Cardiac murmur
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/6
|
|
Investigations
Heart rate increased
|
0.00%
0/8
|
0.00%
0/7
|
16.7%
1/6
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/6
|
|
Metabolism and nutrition disorders
Increased appetite
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
25.0%
2/8
|
14.3%
1/7
|
0.00%
0/6
|
|
Nervous system disorders
Akathesia
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8
|
28.6%
2/7
|
16.7%
1/6
|
|
Nervous system disorders
Drooling
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/6
|
|
Nervous system disorders
Dysaesthesia
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/6
|
|
Nervous system disorders
Dystonia
|
12.5%
1/8
|
14.3%
1/7
|
0.00%
0/6
|
|
Nervous system disorders
Headache
|
50.0%
4/8
|
28.6%
2/7
|
50.0%
3/6
|
|
Nervous system disorders
Hyperaesthesia
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/6
|
|
Nervous system disorders
Hypoaesthesia
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/6
|
|
Nervous system disorders
Psychomotor hyperactivity
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/6
|
|
Nervous system disorders
Sedation
|
0.00%
0/8
|
0.00%
0/7
|
33.3%
2/6
|
|
Nervous system disorders
Somnolence
|
12.5%
1/8
|
0.00%
0/7
|
16.7%
1/6
|
|
Nervous system disorders
Syncope
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/6
|
|
Nervous system disorders
Tremor
|
0.00%
0/8
|
14.3%
1/7
|
16.7%
1/6
|
|
Psychiatric disorders
Hallucination, visual
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/6
|
|
Psychiatric disorders
Hypomania
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/6
|
|
Psychiatric disorders
Insomnia
|
25.0%
2/8
|
0.00%
0/7
|
0.00%
0/6
|
|
Psychiatric disorders
Nightmare
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/6
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/6
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
12.5%
1/8
|
14.3%
1/7
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/8
|
28.6%
2/7
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/6
|
|
Vascular disorders
Hypotension
|
0.00%
0/8
|
0.00%
0/7
|
16.7%
1/6
|
|
Eye disorders
Vision blurred
|
25.0%
2/8
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8
|
42.9%
3/7
|
16.7%
1/6
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8
|
14.3%
1/7
|
16.7%
1/6
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/6
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8
|
28.6%
2/7
|
16.7%
1/6
|
|
General disorders
Chest pain
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/6
|
|
General disorders
Fatigue
|
0.00%
0/8
|
28.6%
2/7
|
0.00%
0/6
|
|
General disorders
Pyrexia
|
0.00%
0/8
|
28.6%
2/7
|
0.00%
0/6
|
|
Infections and infestations
Influenza
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/6
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development & Commercialization, Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place