Trial Outcomes & Findings for Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients With Paroxysmal and Persistent Atrial Fibrillation (NCT NCT01483183)
NCT ID: NCT01483183
Last Updated: 2017-04-10
Results Overview
OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post start of infusion.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
24 hours
Results posted on
2017-04-10
Participant Flow
This trial was conducted in 40 participants at 10 trial sites in the following 3 countries: Germany, Spain, and the United States.
The trial consists of two parts (Part 1 and Part 2). Each part evaluates two populations of participants for cardioversion in a hospital setting; one diagnosed with paroxysmal atrial fibrillation (AF) and the second diagnosed with persistent AF. However, Part 2 was not conducted and therefore is not included in this document.
Participant milestones
| Measure |
Paroxysmal AF - OPC-108459 0.26 mg/kg
Participants received a single dose of OPC-108459 0.26 milligram per kilogram (mg/kg), 10-minute constant rate intravenous (IV) infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 0.40 mg/kg
Participants received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 1.00 mg/kg
Participants received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - Placebo
Participants received placebo dose 10-minute constant rate IV infusion.
|
Persistent AF - OPC-108459 0.26 mg/kg
Participants received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.40 mg/kg
Participants received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.60 mg/kg
Participants received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.35 mg/kg
Participants received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
Participants received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - Placebo
Participants received a single dose of placebo, 10-minute constant rate IV infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
1
|
5
|
3
|
4
|
4
|
6
|
4
|
4
|
5
|
|
Overall Study
COMPLETED
|
4
|
1
|
5
|
3
|
4
|
4
|
4
|
4
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Paroxysmal AF - OPC-108459 0.26 mg/kg
Participants received a single dose of OPC-108459 0.26 milligram per kilogram (mg/kg), 10-minute constant rate intravenous (IV) infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 0.40 mg/kg
Participants received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 1.00 mg/kg
Participants received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - Placebo
Participants received placebo dose 10-minute constant rate IV infusion.
|
Persistent AF - OPC-108459 0.26 mg/kg
Participants received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.40 mg/kg
Participants received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.60 mg/kg
Participants received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.35 mg/kg
Participants received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
Participants received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - Placebo
Participants received a single dose of placebo, 10-minute constant rate IV infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Ascending Dose Study of OPC-108459 Intravenous Infusions in Patients With Paroxysmal and Persistent Atrial Fibrillation
Baseline characteristics by cohort
| Measure |
Paroxysmal AF - OPC-108459 0.26 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 0.40 mg/kg
n=1 Participants
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 1.00 mg/kg
n=5 Participants
Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - Placebo
n=3 Participants
Participants had received placebo dose 10-minute constant rate IV infusion.
|
Persistent AF - OPC-108459 0.26 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.40 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.60 mg/kg
n=6 Participants
Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.35 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - Placebo
n=5 Participants
Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 19.0 • n=5 Participants
|
75.0 years
STANDARD_DEVIATION 0.0 • n=7 Participants
|
68.4 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
61.0 years
STANDARD_DEVIATION 14.1 • n=4 Participants
|
65.0 years
STANDARD_DEVIATION 5.7 • n=21 Participants
|
75.0 years
STANDARD_DEVIATION 10.1 • n=8 Participants
|
63.5 years
STANDARD_DEVIATION 14.7 • n=8 Participants
|
64.8 years
STANDARD_DEVIATION 12.9 • n=24 Participants
|
64.3 years
STANDARD_DEVIATION 7.7 • n=42 Participants
|
70.4 years
STANDARD_DEVIATION 8.8 • n=42 Participants
|
66.6 years
STANDARD_DEVIATION 11.75 • n=42 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
29 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: PK analysis dataset included all participants who had concentration time profiles consistent with proper intravenous infusion.
OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post start of infusion.
Outcome measures
| Measure |
Paroxysmal AF - OPC-108459 0.26 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 0.40 mg/kg
n=1 Participants
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 1.00 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.26 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.40 mg/kg
n=3 Participants
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.60 mg/kg
n=3 Participants
Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.35 mg/kg
n=3 Participants
Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - Placebo
Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximum (Peak) Plasma Concentration (Cmax)
|
1.11 μg/mL
Standard Deviation 0.358
|
1.49 μg/mL
Standard Deviation NA
Due to only 1 participant with evaluable data.
|
2.96 μg/mL
Standard Deviation 0.787
|
1.45 μg/mL
Standard Deviation 1.43
|
1.54 μg/mL
Standard Deviation 0.538
|
1.62 μg/mL
Standard Deviation 1.07
|
NA μg/mL
Standard Deviation NA
The data was not evaluable as the PK was collected from the same line as the infusion. Hence, there is no data available.
|
5.14 μg/mL
Standard Deviation 1.26
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: PK analysis dataset included all participants who had concentration time profiles consistent with proper intravenous infusion.
OPC-108459 was administered as a 10-minute constant rate IV infusion. Blood samples were collected pre-dose (within 45 minutes of dosing), at the end of infusion and 0.5, 1, 2, 4, 8 and 24 hours post infusion.
Outcome measures
| Measure |
Paroxysmal AF - OPC-108459 0.26 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 0.40 mg/kg
n=1 Participants
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 1.00 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.26 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.40 mg/kg
n=3 Participants
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.60 mg/kg
n=3 Participants
Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.35 mg/kg
n=3 Participants
Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - Placebo
Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Area Under the Concentration-time Curve From Time 0 to Time of the Last Measurable Concentration (AUCτ)
|
1.94 μg∙h/mL
Standard Deviation 0.834
|
1.25 μg∙h/mL
Standard Deviation NA
Due to only 1 participant with evaluable data.
|
2.10 μg∙h/mL
Standard Deviation 0.318
|
1.28 μg∙h/mL
Standard Deviation 0.388
|
1.68 μg∙h/mL
Standard Deviation 0.650
|
1.51 μg∙h/mL
Standard Deviation 0.651
|
2.79 μg∙h/mL
Standard Deviation 0.990
|
4.38 μg∙h/mL
Standard Deviation 1.55
|
—
|
—
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Safety dataset included all participants who had received at least one dose of the trial medication.
12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection.
Outcome measures
| Measure |
Paroxysmal AF - OPC-108459 0.26 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 0.40 mg/kg
n=1 Participants
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 1.00 mg/kg
n=5 Participants
Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.26 mg/kg
n=2 Participants
Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.40 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.60 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.35 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
n=3 Participants
Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - Placebo
n=5 Participants
Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1:Maximal Change From Baseline in QT Interval Corrected for Heart Rate Using the Fridericia Formula (QTcF) Within 24 Hour Infusion
Increase
|
15.0 msec
Standard Deviation 8.0
|
NA msec
Standard Deviation NA
Due to only 1 participant with evaluable data.
|
28.8 msec
Standard Deviation 12.0
|
11.5 msec
Standard Deviation 10.6
|
24.5 msec
Standard Deviation 21.4
|
24.0 msec
Standard Deviation 9.5
|
23.3 msec
Standard Deviation 20.2
|
19.7 msec
Standard Deviation 6.5
|
42.5 msec
Standard Deviation 29.0
|
27.4 msec
Standard Deviation 22.9
|
|
Part 1:Maximal Change From Baseline in QT Interval Corrected for Heart Rate Using the Fridericia Formula (QTcF) Within 24 Hour Infusion
Decrease
|
-30.8 msec
Standard Deviation 7.8
|
NA msec
Standard Deviation NA
Due to only 1 participant with evaluable data.
|
-18.2 msec
Standard Deviation 7.8
|
-37.0 msec
Standard Deviation 8.5
|
-15.3 msec
Standard Deviation 9.6
|
-17.8 msec
Standard Deviation 14.1
|
-23.0 msec
Standard Deviation 6.5
|
-18.7 msec
Standard Deviation 16.5
|
-13.3 msec
Standard Deviation 14.0
|
-25.8 msec
Standard Deviation 8.5
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Safety dataset included all participants who had received at least one dose of the trial medication.
12-lead Holter monitors were placed on all participants within 45 minutes prior to dosing. Post dose measurements were made at 2, 4, 6, 8, 10, 20, 30, and 40 minutes and 1, 1.5, 2, 4, 6, 8, 12, 16, and 24 hours post-dose. To achieve consistent recording, Holter sampling will be recorded with the participant recumbent and at rest for at least 10 minutes prior to collection.
Outcome measures
| Measure |
Paroxysmal AF - OPC-108459 0.26 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 0.40 mg/kg
n=1 Participants
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 1.00 mg/kg
n=5 Participants
Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.26 mg/kg
n=2 Participants
Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.40 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.60 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.35 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
n=3 Participants
Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - Placebo
n=5 Participants
Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximal Change From Baseline in Ventricular Rate Within 24 Hour Infusion
Increase
|
22.3 beats/minute
Standard Deviation 18.5
|
NA beats/minute
Standard Deviation NA
Due to only 1 participant with evaluable data.
|
14.6 beats/minute
Standard Deviation 5.0
|
15.5 beats/minute
Standard Deviation 6.4
|
19.5 beats/minute
Standard Deviation 9.1
|
18.5 beats/minute
Standard Deviation 6.2
|
14.8 beats/minute
Standard Deviation 13.1
|
28.0 beats/minute
Standard Deviation 5.0
|
31.5 beats/minute
Standard Deviation 15.6
|
26.0 beats/minute
Standard Deviation 13.2
|
|
Part 1: Maximal Change From Baseline in Ventricular Rate Within 24 Hour Infusion
Decrease
|
-14.3 beats/minute
Standard Deviation 6.6
|
NA beats/minute
Standard Deviation NA
Due to only 1 participant with evaluable data.
|
-29.8 beats/minute
Standard Deviation 26.6
|
-24.0 beats/minute
Standard Deviation 1.4
|
-6.8 beats/minute
Standard Deviation 6.4
|
-12.3 beats/minute
Standard Deviation 3.3
|
-19.8 beats/minute
Standard Deviation 13.5
|
-11.5 beats/minute
Standard Deviation 3.5
|
-8.3 beats/minute
Standard Deviation 6.4
|
-12.4 beats/minute
Standard Deviation 6.4
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: Safety dataset included all participants who had received at least one dose of the trial medication.
Maximum change from baseline in diastolic and systolic blood pressure(BP) collected during vital sign measurements in the 24-hour postdose interval. Participants must be hemodynamically stable defined as a screening systolic blood pressure between 90 to 160 mmHg, diastolic \<100 mmHg. BP was measured after at least 3 minutes in the supine position. BP was measured at predose (within 45 minutes of dosing); 3 and 7 minutes and approximately 1, 4, 8, 12, and 24 hours.
Outcome measures
| Measure |
Paroxysmal AF - OPC-108459 0.26 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 0.40 mg/kg
n=1 Participants
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 1.00 mg/kg
n=5 Participants
Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.26 mg/kg
n=3 Participants
Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.40 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.60 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.35 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - Placebo
n=5 Participants
Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Maximal Change From Baseline in Blood Pressure Within 24 Hour Infusion
Diastolic BP Supine (Decrease)
|
-13.8 mmHg
Standard Deviation 11.4
|
NA mmHg
Standard Deviation NA
Due to only 1 participant with evaluable data.
|
-13.4 mmHg
Standard Deviation 8.7
|
-25.7 mmHg
Standard Deviation 18.3
|
-13.5 mmHg
Standard Deviation 15.3
|
-5.0 mmHg
Standard Deviation 4.2
|
-14.5 mmHg
Standard Deviation 9.3
|
-18.7 mmHg
Standard Deviation 24.6
|
-19.0 mmHg
Standard Deviation 6.2
|
-10.8 mmHg
Standard Deviation 5.5
|
|
Part 1: Maximal Change From Baseline in Blood Pressure Within 24 Hour Infusion
Diastolic BP Supine (Increase)
|
4.3 mmHg
Standard Deviation 2.5
|
26.0 mmHg
Standard Deviation NA
Due to only 1 participant with evaluable data.
|
18.6 mmHg
Standard Deviation 25.1
|
8.0 mmHg
Standard Deviation 11.3
|
5.3 mmHg
Standard Deviation 5.1
|
5.0 mmHg
Standard Deviation 2.6
|
1.7 mmHg
Standard Deviation 0.6
|
9.8 mmHg
Standard Deviation 7.9
|
21.0 mmHg
Standard Deviation 6.7
|
10.2 mmHg
Standard Deviation 6.7
|
|
Part 1: Maximal Change From Baseline in Blood Pressure Within 24 Hour Infusion
Systolic BP Supine (Decrease)
|
-11.3 mmHg
Standard Deviation 6.4
|
NA mmHg
Standard Deviation NA
Due to only 1 participant with evaluable data.
|
-20.8 mmHg
Standard Deviation 14.1
|
-18.3 mmHg
Standard Deviation 18.6
|
-7.8 mmHg
Standard Deviation 5.7
|
-3.0 mmHg
Standard Deviation 1.4
|
-9.0 mmHg
Standard Deviation 6.2
|
-17.3 mmHg
Standard Deviation 13.7
|
-24.5 mmHg
Standard Deviation 10.5
|
-23.0 mmHg
Standard Deviation 15.1
|
|
Part 1: Maximal Change From Baseline in Blood Pressure Within 24 Hour Infusion
Systolic BP Supine (Increase)
|
14.3 mmHg
Standard Deviation 10.4
|
42.0 mmHg
Standard Deviation NA
Due to only 1 participant with evaluable data.
|
16.6 mmHg
Standard Deviation 11.9
|
14.3 mmHg
Standard Deviation 23.1
|
7.5 mmHg
Standard Deviation 8.4
|
11.3 mmHg
Standard Deviation 8.2
|
8.5 mmHg
Standard Deviation 7.5
|
21.7 mmHg
Standard Deviation 6.4
|
15.0 mmHg
Standard Deviation 6.4
|
12.1 mmHg
Standard Deviation 8.6
|
PRIMARY outcome
Timeframe: 24 hoursThe trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 hoursThe trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 hoursThe trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 hoursThe trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 hoursThe trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 hoursThe trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 hoursThe trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 24 hoursThe trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30 minutesPopulation: Safety dataset included all participants who had received at least one dose of the trial medication.
Percent of participants with NSR, defined as NSR for at least 1 minute within 30 minutes of the end of OPC-108459 infusion.
Outcome measures
| Measure |
Paroxysmal AF - OPC-108459 0.26 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 0.40 mg/kg
n=1 Participants
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 1.00 mg/kg
n=5 Participants
Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.26 mg/kg
n=3 Participants
Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.40 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.60 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.35 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
n=4 Participants
Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - Placebo
n=5 Participants
Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part 1: Percentage of Participants With NSR
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 24 hoursThe trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 hoursThe trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 168 hoursThe trial was terminated after Part 1 enrollment completed. All analyses described in this document were performed on Part 1 data. However, Part 2 was not conducted and therefore is not included in this document.
Outcome measures
Outcome data not reported
Adverse Events
Paroxysmal AF - OPC-108459 0.26 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Paroxysmal AF - OPC-108459 0.40 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Paroxysmal AF - OPC-108459 1.00 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Paroxysmal AF - Placebo
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Persistent AF - OPC-108459 0.26 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Persistent AF - OPC-108459 0.40 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Persistent AF - OPC-108459 0.60 mg/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Persistent AF - OPC-108459 1.35 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Persistent AF - OPC-108459 1.55 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Persistent AF - Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paroxysmal AF - OPC-108459 0.26 mg/kg
n=4 participants at risk
Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 0.40 mg/kg
n=1 participants at risk
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 1.00 mg/kg
n=5 participants at risk
Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - Placebo
n=3 participants at risk
Participants had received placebo dose 10-minute constant rate IV infusion.
|
Persistent AF - OPC-108459 0.26 mg/kg
n=4 participants at risk
Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.40 mg/kg
n=4 participants at risk
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.60 mg/kg
n=4 participants at risk
Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.35 mg/kg
n=4 participants at risk
Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
n=4 participants at risk
Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - Placebo
n=5 participants at risk
Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Major Depression
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
33.3%
1/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
20.0%
1/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
Other adverse events
| Measure |
Paroxysmal AF - OPC-108459 0.26 mg/kg
n=4 participants at risk
Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 0.40 mg/kg
n=1 participants at risk
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - OPC-108459 1.00 mg/kg
n=5 participants at risk
Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Paroxysmal AF - Placebo
n=3 participants at risk
Participants had received placebo dose 10-minute constant rate IV infusion.
|
Persistent AF - OPC-108459 0.26 mg/kg
n=4 participants at risk
Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.40 mg/kg
n=4 participants at risk
Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 0.60 mg/kg
n=4 participants at risk
Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.35 mg/kg
n=4 participants at risk
Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - OPC-108459 1.55 mg/kg
n=4 participants at risk
Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
|
Persistent AF - Placebo
n=5 participants at risk
Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
20.0%
1/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
25.0%
1/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
20.0%
1/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
20.0%
1/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
20.0%
1/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
100.0%
1/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
20.0%
1/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
100.0%
1/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
General disorders
Infusion site pain
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
100.0%
1/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
Infections and infestations
Tooth infection
|
25.0%
1/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
20.0%
1/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
20.0%
1/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
100.0%
1/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
20.0%
1/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
25.0%
1/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
25.0%
1/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
20.0%
1/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
20.0%
1/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
20.0%
1/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
25.0%
1/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/1 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/3 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
0.00%
0/4 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
20.0%
1/5 • Adverse events were reported from the signing of the informed consent throughout the 8-day study until the final follow-up phone call Day 31 (+2) days post dose.
|
Additional Information
Global Medical Affairs
Otsuka Pharmaceutical Development and Commercialization, Inc.
Phone: 800 562-3974
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER