Trial Outcomes & Findings for Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects (NCT NCT01520987)
NCT ID: NCT01520987
Last Updated: 2016-06-20
Results Overview
Cmax - maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
105 participants
Primary outcome timeframe
Day 1
Results posted on
2016-06-20
Participant Flow
Participant milestones
| Measure |
Caucasian 5 mg OPC
OPC, opicapone, BIA 9-1067 (once-daily).
|
Caucasian 25 mg OPC
OPC, opicapone, BIA 9-1067 (once-daily).
|
Caucasian 50 mg OPC
OPC, opicapone, BIA 9-1067 (once-daily).
|
Caucasian Placebo
Placebo, PLC
Placebo: once-daily
|
Japanese 5 mg OPC
OPC, opicapone, BIA 9-1067 (once-daily).
|
Japanese 25 mg OPC
OPC, opicapone, BIA 9-1067 (once-daily).
|
Japanese 50 mg OPC
OPC, opicapone, BIA 9-1067 (once-daily).
|
Japanese Placebo
Placebo, PLC
Placebo: once-daily
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
12
|
11
|
15
|
14
|
14
|
12
|
14
|
|
Overall Study
Dosed
|
13
|
12
|
11
|
15
|
14
|
14
|
12
|
14
|
|
Overall Study
COMPLETED
|
12
|
12
|
11
|
15
|
14
|
13
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Caucasian 5 mg OPC
OPC, opicapone, BIA 9-1067 (once-daily).
|
Caucasian 25 mg OPC
OPC, opicapone, BIA 9-1067 (once-daily).
|
Caucasian 50 mg OPC
OPC, opicapone, BIA 9-1067 (once-daily).
|
Caucasian Placebo
Placebo, PLC
Placebo: once-daily
|
Japanese 5 mg OPC
OPC, opicapone, BIA 9-1067 (once-daily).
|
Japanese 25 mg OPC
OPC, opicapone, BIA 9-1067 (once-daily).
|
Japanese 50 mg OPC
OPC, opicapone, BIA 9-1067 (once-daily).
|
Japanese Placebo
Placebo, PLC
Placebo: once-daily
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Pharmacokinetics of BIA 9-1067 in Healthy Japanese and Caucasian Subjects
Baseline characteristics by cohort
| Measure |
Caucasian 5 mg OPC
n=13 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 25 mg OPC
n=12 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 50 mg OPC
n=11 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian Placebo
n=15 Participants
Placebo, PLC
Placebo: once-daily
|
Japanese 5 mg OPC
n=14 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 25 mg OPC
n=14 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 50 mg OPC
n=12 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese Placebo
n=14 Participants
Placebo, PLC
Placebo: once-daily
|
Total
n=105 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
14 Participants
n=6 Participants
|
105 Participants
n=6 Participants
|
|
Age, Categorical
>=65 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
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
8 Participants
n=6 Participants
|
60 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
45 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Day 1Cmax - maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
Outcome measures
| Measure |
Caucasian 5 mg OPC
n=13 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 25 mg OPC
n=11 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 50 mg OPC
n=11 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 5 mg OPC
n=14 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 25 mg OPC
n=14 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 50 mg OPC
n=12 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
|---|---|---|---|---|---|---|
|
Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)
|
182 ng/mL
Standard Deviation 64.5
|
794 ng/mL
Standard Deviation 392
|
1540 ng/mL
Standard Deviation 493
|
176 ng/mL
Standard Deviation 93.6
|
797 ng/mL
Standard Deviation 323
|
1736 ng/mL
Standard Deviation 381
|
PRIMARY outcome
Timeframe: Day 10Cmax - maximum observed plasma concentration following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose
Outcome measures
| Measure |
Caucasian 5 mg OPC
n=13 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 25 mg OPC
n=12 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 50 mg OPC
n=11 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 5 mg OPC
n=14 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 25 mg OPC
n=13 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 50 mg OPC
n=12 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
|---|---|---|---|---|---|---|
|
Cmax of BIA 9-1067 - Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)
|
226 ng/mL
Standard Deviation 110
|
774 ng/mL
Standard Deviation 361
|
1550 ng/mL
Standard Deviation 655
|
276 ng/mL
Standard Deviation 130
|
959 ng/mL
Standard Deviation 273
|
1785 ng/mL
Standard Deviation 431
|
PRIMARY outcome
Timeframe: Day 1AUC0-t - area under the concentration-time curve (AUC) from time zero to last time point with concentrations above the lower limit of quantitation of BIA 9-1067 following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose.
Outcome measures
| Measure |
Caucasian 5 mg OPC
n=13 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 25 mg OPC
n=11 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 50 mg OPC
n=11 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 5 mg OPC
n=14 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 25 mg OPC
n=14 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 50 mg OPC
n=12 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
|---|---|---|---|---|---|---|
|
AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 1)
|
267 ng.h/mL
Standard Deviation 113
|
2013 ng.h/mL
Standard Deviation 800
|
3727 ng.h/mL
Standard Deviation 1726
|
319 ng.h/mL
Standard Deviation 154
|
1886 ng.h/mL
Standard Deviation 692
|
4438 ng.h/mL
Standard Deviation 1151
|
PRIMARY outcome
Timeframe: Day 10AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose
Outcome measures
| Measure |
Caucasian 5 mg OPC
n=13 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 25 mg OPC
n=12 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 50 mg OPC
n=11 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 5 mg OPC
n=14 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 25 mg OPC
n=13 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 50 mg OPC
n=12 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
|---|---|---|---|---|---|---|
|
AUC0-t - Area Under the Concentration-time Curve (AUC) From Time Zero to Last Time Point With Concentrations Above the Lower Limit of Quantitation of BIA 9-1067 (Day 10)
|
349 ng.h/mL
Standard Deviation 169
|
2024 ng.h/mL
Standard Deviation 820
|
3999 ng.h/mL
Standard Deviation 1770
|
441 ng.h/mL
Standard Deviation 139
|
2222 ng.h/mL
Standard Deviation 407
|
4464 ng.h/mL
Standard Deviation 932
|
PRIMARY outcome
Timeframe: Day 1AUC0-â - area under the concentration of BIA 9-1067-time curve (AUC) from time zero to infinity following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose
Outcome measures
| Measure |
Caucasian 5 mg OPC
n=10 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 25 mg OPC
n=11 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 50 mg OPC
n=11 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 5 mg OPC
n=11 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 25 mg OPC
n=13 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 50 mg OPC
n=12 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
|---|---|---|---|---|---|---|
|
AUC0-â - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 1)
|
338 ng.h/mL
Standard Deviation 48.6
|
2039 ng.h/mL
Standard Deviation 798
|
3756 ng.h/mL
Standard Deviation 1734
|
357 ng.h/mL
Standard Deviation 163
|
1976 ng.h/mL
Standard Deviation 673
|
4470 ng.h/mL
Standard Deviation 1147
|
PRIMARY outcome
Timeframe: Day 10AUC0-â - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose
Outcome measures
| Measure |
Caucasian 5 mg OPC
n=13 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 25 mg OPC
n=12 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 50 mg OPC
n=11 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 5 mg OPC
n=14 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 25 mg OPC
n=13 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 50 mg OPC
n=12 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
|---|---|---|---|---|---|---|
|
AUC0-â - Area Under the Concentration of BIA 9-1067-time Curve (AUC) From Time Zero to Infinity (Day 10)
|
409 ng.h/mL
Standard Deviation 147
|
2056 ng.h/mL
Standard Deviation 817
|
4028 ng.h/mL
Standard Deviation 1786
|
465 ng.h/mL
Standard Deviation 145
|
2240 ng.h/mL
Standard Deviation 406
|
4510 ng.h/mL
Standard Deviation 938
|
PRIMARY outcome
Timeframe: Day 1Tmax of BIA 9-1067 - time taken to reach maximum observed plasma concentration following single (Day 1) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: on Day 1 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours post-dose
Outcome measures
| Measure |
Caucasian 5 mg OPC
n=13 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 25 mg OPC
n=11 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 50 mg OPC
n=11 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 5 mg OPC
n=14 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 25 mg OPC
n=14 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 50 mg OPC
n=12 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
|---|---|---|---|---|---|---|
|
Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 1)
|
2.0 hours
Interval 0.75 to 5.0
|
2.0 hours
Interval 1.5 to 4.0
|
3.0 hours
Interval 1.5 to 3.0
|
2.0 hours
Interval 1.0 to 5.0
|
2.0 hours
Interval 1.0 to 8.0
|
2.0 hours
Interval 0.75 to 5.0
|
PRIMARY outcome
Timeframe: Day 10Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 following Last (Day 10) oral administrations of 5, 25 and 50 mg OPC in healthy Japanese and matched healthy Caucasian subjects. Blood samples collected for PK analysis at the following timepoints: Day 10 at pre-dose (within 1 hour before dose administration) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 96, 120, and 144 hours post-dose
Outcome measures
| Measure |
Caucasian 5 mg OPC
n=13 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 25 mg OPC
n=12 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 50 mg OPC
n=11 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 5 mg OPC
n=14 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 25 mg OPC
n=13 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 50 mg OPC
n=12 Participants
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
|---|---|---|---|---|---|---|
|
Tmax of BIA 9-1067 - Time Taken to Reach Maximum Observed Plasma Concentration of BIA 9-1067 (Day 10)
|
1.00 hours
Interval 0.5 to 5.0
|
2.00 hours
Interval 1.0 to 4.0
|
1.50 hours
Interval 0.5 to 3.0
|
2.00 hours
Interval 0.75 to 5.0
|
2.00 hours
Interval 0.5 to 4.0
|
2.00 hours
Interval 1.0 to 4.0
|
Adverse Events
Caucasian 5 mg OPC
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Caucasian 25 mg OPC
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Caucasian 50 mg OPC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Caucasian Placebo
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Japanese 5 mg OPC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Japanese 25 mg OPC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Japanese 50 mg OPC
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Japanese Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Caucasian 5 mg OPC
n=13 participants at risk
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 25 mg OPC
n=12 participants at risk
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian 50 mg OPC
n=11 participants at risk
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Caucasian Placebo
n=15 participants at risk
Placebo, PLC
Placebo: once-daily
|
Japanese 5 mg OPC
n=14 participants at risk
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 25 mg OPC
n=14 participants at risk
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese 50 mg OPC
n=12 participants at risk
OPC, opicapone, BIA 9-1067
BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
|
Japanese Placebo
n=14 participants at risk
Placebo, PLC
Placebo: once-daily
|
|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/13
|
8.3%
1/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/14
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
6.7%
1/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Eye disorders
Visual impairment
|
7.7%
1/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Infections and infestations
Hordeolum
|
0.00%
0/13
|
8.3%
1/12
|
0.00%
0/11
|
6.7%
1/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
7.1%
1/14
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Vascular disorders
Hot flush
|
7.7%
1/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
General disorders
Energy increased
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
|
General disorders
Tenderness
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
7.1%
1/14
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Nervous system disorders
Somnolence
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
7.1%
1/14
|
|
Nervous system disorders
Tension headache
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
16.7%
2/12
|
0.00%
0/14
|
|
Nervous system disorders
Presyncope
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Sunburn
|
7.7%
1/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Gastrointestinal disorders
Nausea
|
23.1%
3/13
|
0.00%
0/12
|
0.00%
0/11
|
6.7%
1/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
7.1%
1/14
|
|
Gastrointestinal disorders
Dyspepsia
|
7.7%
1/13
|
0.00%
0/12
|
9.1%
1/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13
|
0.00%
0/12
|
9.1%
1/11
|
6.7%
1/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
7.1%
1/14
|
|
Nervous system disorders
Headache
|
0.00%
0/13
|
0.00%
0/12
|
9.1%
1/11
|
6.7%
1/15
|
14.3%
2/14
|
7.1%
1/14
|
8.3%
1/12
|
14.3%
2/14
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/13
|
0.00%
0/12
|
9.1%
1/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
7.7%
1/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/13
|
0.00%
0/12
|
9.1%
1/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stifness
|
7.7%
1/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/13
|
8.3%
1/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
7.7%
1/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13
|
0.00%
0/12
|
9.1%
1/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
General disorders
Vessel puncture site haematoma
|
30.8%
4/13
|
25.0%
3/12
|
0.00%
0/11
|
13.3%
2/15
|
7.1%
1/14
|
14.3%
2/14
|
25.0%
3/12
|
14.3%
2/14
|
|
General disorders
Vessel puncture site pain
|
7.7%
1/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
7.1%
1/14
|
8.3%
1/12
|
0.00%
0/14
|
|
General disorders
Fatigue
|
7.7%
1/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
General disorders
Irritability
|
0.00%
0/13
|
0.00%
0/12
|
9.1%
1/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/13
|
0.00%
0/12
|
9.1%
1/11
|
6.7%
1/15
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/13
|
0.00%
0/12
|
9.1%
1/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Nervous system disorders
Syncope
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
7.1%
1/14
|
0.00%
0/14
|
0.00%
0/12
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Laceratioin
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
7.1%
1/14
|
|
Infections and infestations
Viral infection
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/14
|
|
Cardiac disorders
Palpitations
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
7.1%
1/14
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
7.1%
1/14
|
|
Eye disorders
Eye irritation
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/14
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/13
|
0.00%
0/12
|
0.00%
0/11
|
0.00%
0/15
|
0.00%
0/14
|
0.00%
0/14
|
0.00%
0/12
|
7.1%
1/14
|
Additional Information
Head of Clinical Research
Bial - Portela & CÂȘ, S.A.
Phone: +351 229 866 100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER