Trial Outcomes & Findings for A Trial to Determine the Safety, Pharmacokinetics, and Efficacy of OPC-108459 Administered as a Single Intravenous Dose to Patients With Paroxysmal or Persistent Atrial Fibrillation (AF) (NCT NCT02069119)
NCT ID: NCT02069119
Last Updated: 2018-11-05
Results Overview
24 subjects with paroxysmal AF, 6 subjects per cohort (5 for OPC-108459 and one for placebo), 4 dose steps; Step 1: 0.4 mg/kg, Step 2: 0.8 mg/kg, Step 3: 1.6 mg/kg, Step 4: 2.6 mg/kg The number of subjects achieving NSR within 90 minutes after the start of IMP administration and sustaining NSR for at least one minute.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
48 participants
Primary outcome timeframe
90 minutes
Results posted on
2018-11-05
Participant Flow
Participant milestones
| Measure |
OPC-108459（Paroxysmal AF）
Randomized: 20/24 subjects
|
Placebo（Paroxysmal AF）
Randomized: 4/24 subjects
|
OPC-108459 (Persistent AF)
Randomized: 20/24 subjects
|
Placebo (Persistent AF）
Randomized: 4/24 subjects
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
4
|
20
|
4
|
|
Overall Study
COMPLETED
|
20
|
4
|
20
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial to Determine the Safety, Pharmacokinetics, and Efficacy of OPC-108459 Administered as a Single Intravenous Dose to Patients With Paroxysmal or Persistent Atrial Fibrillation (AF)
Baseline characteristics by cohort
| Measure |
OPC-108459（Paroxysmal）
n=20 Participants
|
Placebo（Paroxysmal）
n=4 Participants
|
OPC-108459（Persistent）
n=20 Participants
|
Placebo（Persistent）
n=4 Participants
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
17 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Age, Continuous
|
70.1 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
67.5 years
STANDARD_DEVIATION 3.8 • n=7 Participants
|
65.4 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
60.0 years
STANDARD_DEVIATION 13.3 • n=4 Participants
|
67.1 years
STANDARD_DEVIATION 8.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
|
Region of Enrollment
Japan
|
20 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 90 minutes24 subjects with paroxysmal AF, 6 subjects per cohort (5 for OPC-108459 and one for placebo), 4 dose steps; Step 1: 0.4 mg/kg, Step 2: 0.8 mg/kg, Step 3: 1.6 mg/kg, Step 4: 2.6 mg/kg The number of subjects achieving NSR within 90 minutes after the start of IMP administration and sustaining NSR for at least one minute.
Outcome measures
| Measure |
OPC-108459 Step 1 (0.4 mg/kg)
n=5 Participants
|
OPC-108459 Step 2 （0.8 mg/kg）
n=5 Participants
|
OPC-108459 Step 3 （1.6mg/kg）
n=5 Participants
|
OPC-108459 Step 4 （2.6 mg/kg）
n=5 Participants
|
Placebo
n=4 Participants
|
|---|---|---|---|---|---|
|
Subjects Achieving Normal Sinus Rhythm (NSR) in Patients With Paroxysmal AF
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 90 minutes24 subjects with persistent AF, 6 subjects per cohort (5 for OPC-108459 and one for placebo), 4 dose steps; Step 1: 0.4 mg/kg, Step 2: 0.8 mg/kg, Step 3: 1.6 mg/kg, Step 4: 2.6 mg/kg The number of subjects achieving NSR within 90 minutes after the start of IMP administration and sustaining NSR for at least one minute. No subjects achieved NSR within 90 minutes after the start of IMP administration in the persistent AF cohort.
Outcome measures
| Measure |
OPC-108459 Step 1 (0.4 mg/kg)
n=5 Participants
|
OPC-108459 Step 2 （0.8 mg/kg）
n=5 Participants
|
OPC-108459 Step 3 （1.6mg/kg）
n=5 Participants
|
OPC-108459 Step 4 （2.6 mg/kg）
n=5 Participants
|
Placebo
n=4 Participants
|
|---|---|---|---|---|---|
|
Subjects Achieving NSR in Patients With Persistent AF
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 0, 30, 50 minute and 2, 4, 8, 24 hourOf 20 subjects for whom plasma OPC-108459 concentrations were measured, 19 subjects were included in the PK analysis, and one subject was excluded.
Outcome measures
| Measure |
OPC-108459 Step 1 (0.4 mg/kg)
n=5 Participants
|
OPC-108459 Step 2 （0.8 mg/kg）
n=5 Participants
|
OPC-108459 Step 3 （1.6mg/kg）
n=5 Participants
|
OPC-108459 Step 4 （2.6 mg/kg）
n=4 Participants
|
Placebo
|
|---|---|---|---|---|---|
|
Cmax of Plasma OPC-108459 in Patients With Paroxysmal AF
|
786.2 ng/mL
Standard Deviation 228.1
|
1942.0 ng/mL
Standard Deviation 2428.0
|
3629.0 ng/mL
Standard Deviation 499.1
|
5316.0 ng/mL
Standard Deviation 1230.0
|
—
|
PRIMARY outcome
Timeframe: 0, 30, 50 minute and 2, 4, 8, 24 hourOf 20 subjects for whom plasma OPC-108459 concentrations were measured, all subjects were included in the PK analysis.
Outcome measures
| Measure |
OPC-108459 Step 1 (0.4 mg/kg)
n=5 Participants
|
OPC-108459 Step 2 （0.8 mg/kg）
n=5 Participants
|
OPC-108459 Step 3 （1.6mg/kg）
n=5 Participants
|
OPC-108459 Step 4 （2.6 mg/kg）
n=5 Participants
|
Placebo
|
|---|---|---|---|---|---|
|
Cmax of Plasma OPC-108459 in Patients With Persistent AF
|
1037.0 ng/mL
Standard Deviation 154.5
|
1593.0 ng/mL
Standard Deviation 382.1
|
3676.0 ng/mL
Standard Deviation 826.8
|
6412.0 ng/mL
Standard Deviation 964.6
|
—
|
Adverse Events
OPC-108459（Paroxysmal）
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
OPC-108459（Persistent）
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo（Paroxysmal）
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo（Persistent）
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OPC-108459（Paroxysmal）
n=20 participants at risk
A total of 112 subjects were enrolled and screened, and 48 subjects were randomized to either the OPC-108459 group or placebo group. Of the 48 subjects, 24 subjects were randomized to paroxysmal AF cohort (20 for the OPC-108459, 4 for the placebo). All the randomized subjects received the Interventional medicinal product (IMP) administration and were included in the FAS. Of the 24 subjects, 18 subjects were included in the PK analysis set.
|
OPC-108459（Persistent）
n=20 participants at risk
Of the 48 subjects, 24 subjects were randomized to persistent AF cohort (20 for the OPC-108459, 4 for the placebo). All the randomized subjects in Persistent AF cohort received the IMP administration and were included in the FAS and PK analysis set.
|
Placebo（Paroxysmal）
n=4 participants at risk
A total of 112 subjects were enrolled and screened, and 48 subjects were randomized to either the OPC-108459 group or placebo group. Of the 48 subjects, 24 subjects were randomized to paroxysmal AF cohort (20 for the OPC-108459, 4 for the placebo). All the randomized subjects received the Interventional medicinal product (IMP) administration and were included in the FAS. Of the 24 subjects, 18 subjects were included in the PK analysis set.
|
Placebo（Persistent）
n=4 participants at risk
Of the 48 subjects, 24 subjects were randomized to persistent AF cohort (20 for the OPC-108459, 4 for the placebo). All the randomized subjects in Persistent AF cohort received the IMP administration and were included in the FAS and PK analysis set.
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
Other adverse events
| Measure |
OPC-108459（Paroxysmal）
n=20 participants at risk
A total of 112 subjects were enrolled and screened, and 48 subjects were randomized to either the OPC-108459 group or placebo group. Of the 48 subjects, 24 subjects were randomized to paroxysmal AF cohort (20 for the OPC-108459, 4 for the placebo). All the randomized subjects received the Interventional medicinal product (IMP) administration and were included in the FAS. Of the 24 subjects, 18 subjects were included in the PK analysis set.
|
OPC-108459（Persistent）
n=20 participants at risk
Of the 48 subjects, 24 subjects were randomized to persistent AF cohort (20 for the OPC-108459, 4 for the placebo). All the randomized subjects in Persistent AF cohort received the IMP administration and were included in the FAS and PK analysis set.
|
Placebo（Paroxysmal）
n=4 participants at risk
A total of 112 subjects were enrolled and screened, and 48 subjects were randomized to either the OPC-108459 group or placebo group. Of the 48 subjects, 24 subjects were randomized to paroxysmal AF cohort (20 for the OPC-108459, 4 for the placebo). All the randomized subjects received the Interventional medicinal product (IMP) administration and were included in the FAS. Of the 24 subjects, 18 subjects were included in the PK analysis set.
|
Placebo（Persistent）
n=4 participants at risk
Of the 48 subjects, 24 subjects were randomized to persistent AF cohort (20 for the OPC-108459, 4 for the placebo). All the randomized subjects in Persistent AF cohort received the IMP administration and were included in the FAS and PK analysis set.
|
|---|---|---|---|---|
|
Infections and infestations
Cystitis
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Infections and infestations
Oral herpes
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Nervous system disorders
Headache
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Nervous system disorders
Presyncope
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Eye disorders
Mydriasis
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Cardiac disorders
Atrial fibrillation
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Cardiac disorders
Atrial flutter
|
10.0%
2/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
25.0%
1/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Cardiac disorders
Atrial tachycardi
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
25.0%
1/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
25.0%
1/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
25.0%
1/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Cardiac disorders
Sinus node dysfunction
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
25.0%
1/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
10.0%
2/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
10.0%
2/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Vascular disorders
Vascular pain
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
15.0%
3/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
50.0%
2/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
10.0%
2/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
General disorders
Chest discomfort
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
25.0%
1/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
General disorders
Injection site pain
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
General disorders
Pyrexia
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
10.0%
2/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
25.0%
1/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Investigations
Blood pressure decreased
|
15.0%
3/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Investigations
C-reactive protein increased
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Investigations
Glucose urine present
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
10.0%
2/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Investigations
White blood cell count increased
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Investigations
Heart rate increased1
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Investigations
Electrocardiogram RR interval prolonged
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
25.0%
1/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Investigations
Oxygen saturation decreased
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Investigations
Respiratory rate increased
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Injury, poisoning and procedural complications
Heat illness
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
25.0%
1/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
5.0%
1/20 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
0.00%
0/4 • From the start date of IMP administration to date of the final examination (up to 30 days after IMP administration)
|
Additional Information
Director of Clinical Trials
Otsuka Pharmaceutical Co., Ltd.
Phone: +81-3-6361-7366
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place