Trial Outcomes & Findings for Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics (NCT NCT02169414)
NCT ID: NCT02169414
Last Updated: 2015-12-24
Results Overview
Cmax - Maximum plasma concentration of levodopa following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
74 participants
Primary outcome timeframe
pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.
Results posted on
2015-12-24
Participant Flow
Participant milestones
| Measure |
BIA 9-1067 5 mg
1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
BIA 9-1067 15 mg
3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
BIA 9-1067 50 mg
2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 25 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
Placebo
3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
18
|
18
|
|
Overall Study
BIA 9-1067 + Levodopa/Carbidopa
|
18
|
19
|
18
|
18
|
|
Overall Study
BIA 9-1067 + Levodopa/Benserazide
|
18
|
18
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
BIA 9-1067 5 mg
1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
BIA 9-1067 15 mg
3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
BIA 9-1067 50 mg
2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 25 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
Placebo
3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Effect of Three Multiple-dose Regimens of BIA 9 1067 at Steady-state on the Levodopa Pharmacokinetics
Baseline characteristics by cohort
| Measure |
Placebo
n=18 Participants
3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
BIA 9-1067 5 mg
n=19 Participants
1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
BIA 9-1067 15 mg
n=19 Participants
3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
BIA 9-1067 50 mg
n=18 Participants
2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 25 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
Total
n=74 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
74 Participants
n=21 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
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.Cmax - Maximum plasma concentration of levodopa following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11
Outcome measures
| Measure |
Placebo
n=18 Participants
3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 5 mg
n=18 Participants
1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 15 mg
n=19 Participants
3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
|
BIA 9-1067 50 mg
n=18 Participants
2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
|---|---|---|---|---|
|
Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa)
|
966.6 ng/mL
Standard Deviation 313.2
|
1026.8 ng/mL
Standard Deviation 445.2
|
1097.9 ng/mL
Standard Deviation 353.2
|
1019.7 ng/mL
Standard Deviation 282.1
|
PRIMARY outcome
Timeframe: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.Tmax - Time to Reach maximum plasma concentration of levodopa following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11
Outcome measures
| Measure |
Placebo
n=18 Participants
3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 5 mg
n=18 Participants
1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 15 mg
n=19 Participants
3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
|
BIA 9-1067 50 mg
n=18 Participants
2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
|---|---|---|---|---|
|
Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Carbidopa)
|
0.78 hours
Standard Deviation 0.49
|
1 hours
Standard Deviation 0.84
|
0.95 hours
Standard Deviation 0.55
|
1 hours
Standard Deviation 0.59
|
PRIMARY outcome
Timeframe: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11
Outcome measures
| Measure |
Placebo
n=18 Participants
3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 5 mg
n=18 Participants
1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 15 mg
n=19 Participants
3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
|
BIA 9-1067 50 mg
n=18 Participants
2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
|---|---|---|---|---|
|
AUC0-â - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Carbidopa)
|
1861.3 ng.h/mL
Standard Deviation 466.5
|
2332.3 ng.h/mL
Standard Deviation 634.9
|
2736.8 ng.h/mL
Standard Deviation 767
|
3182.6 ng.h/mL
Standard Deviation 814.1
|
PRIMARY outcome
Timeframe: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.AUC0-t - Area under the plasma concentration-time curve (AUC) of levodopa from time zero to the last sampling time following a single oral administration of 100/25 mg levodopa/carbidopa administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 11
Outcome measures
| Measure |
Placebo
n=18 Participants
3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 5 mg
n=18 Participants
1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 15 mg
n=19 Participants
3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
|
BIA 9-1067 50 mg
n=18 Participants
2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
|---|---|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Carbidopa)
|
1788.3 ng.h/mL
Standard Deviation 461.2
|
2219.7 ng.h/mL
Standard Deviation 616.4
|
2584.3 ng.h/mL
Standard Deviation 794.9
|
2975.9 ng.h/mL
Standard Deviation 799
|
PRIMARY outcome
Timeframe: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18
Outcome measures
| Measure |
Placebo
n=18 Participants
3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 5 mg
n=18 Participants
1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 15 mg
n=18 Participants
3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
|
BIA 9-1067 50 mg
n=18 Participants
2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
|---|---|---|---|---|
|
Cmax - Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide )
|
1770.3 ng/mL
Standard Deviation 741.2
|
1379.8 ng/mL
Standard Deviation 605.1
|
2118.3 ng/mL
Standard Deviation 573.4
|
1813.7 ng/mL
Standard Deviation 811.3
|
PRIMARY outcome
Timeframe: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18
Outcome measures
| Measure |
Placebo
n=18 Participants
3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 5 mg
n=18 Participants
1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 15 mg
n=18 Participants
3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
|
BIA 9-1067 50 mg
n=18 Participants
2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
|---|---|---|---|---|
|
Tmax - Time to Reach Maximum Plasma Concentration of Levodopa (Levodopa/Benserazide)
|
0.89 hours
Standard Deviation 0.47
|
1.08 hours
Standard Deviation 0.52
|
0.7 hours
Standard Deviation 0.3
|
1.08 hours
Standard Deviation 0.62
|
PRIMARY outcome
Timeframe: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-dose.Levodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18
Outcome measures
| Measure |
Placebo
n=18 Participants
3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 5 mg
n=18 Participants
1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 15 mg
n=18 Participants
3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
|
BIA 9-1067 50 mg
n=18 Participants
2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
|---|---|---|---|---|
|
AUC0-â - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to Infinity (Levodopa/Benserazide)
|
2360.3 ng.h/mL
Standard Deviation 738.9
|
2660.9 ng.h/mL
Standard Deviation 593.2
|
3655.9 ng.h/mL
Standard Deviation 553.1
|
3979.5 ng.h/mL
Standard Deviation 1406.1
|
PRIMARY outcome
Timeframe: pre-dose and at the following times post-dose: 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 hours post-doseLevodopa pharmacokinetic parameters following a single oral administration of 100/25 mg levodopa/benserazide administered 12 h after BIA 9-1067 (5 mg, 15 mg and 50 mg) or placebo on Day 18
Outcome measures
| Measure |
Placebo
n=18 Participants
3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 5 mg
n=18 Participants
1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
BIA 9-1067 15 mg
n=18 Participants
3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
|
BIA 9-1067 50 mg
n=18 Participants
2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
|
|---|---|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration-time Curve (AUC) of Levodopa From Time Zero to the Last Sampling Time at Which the Drug Concentration Was at or Above the Lower Limit of Quantification. (Levodopa/Benserazide)
|
2278.8 ng.h/mL
Standard Deviation 730.4
|
2549.8 ng.h/mL
Standard Deviation 586.6
|
3521.1 ng.h/mL
Standard Deviation 557.7
|
3819.7 ng.h/mL
Standard Deviation 1391.5
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
BIA 9-1067 5 mg
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
BIA 9-1067 15 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
BIA 9-1067 50 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=18 participants at risk
3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
BIA 9-1067 5 mg
n=19 participants at risk
1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
BIA 9-1067 15 mg
n=19 participants at risk
3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
BIA 9-1067 50 mg
n=18 participants at risk
2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 25 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
|---|---|---|---|---|
|
Nervous system disorders
Right Peripheral Facial Paralysis
|
5.6%
1/18
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/18
|
Other adverse events
| Measure |
Placebo
n=18 participants at risk
3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
BIA 9-1067 5 mg
n=19 participants at risk
1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
BIA 9-1067 15 mg
n=19 participants at risk
3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 5 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
BIA 9-1067 50 mg
n=18 participants at risk
2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.
BIA 9-1067 25 mg: OPC, Opicapone
levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
Placebo: PLC, Placebo
levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
5.6%
1/18
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Eye disorders
Blepharospasm
|
5.6%
1/18
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18
|
10.5%
2/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/18
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18
|
0.00%
0/19
|
21.1%
4/19
|
5.6%
1/18
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
General disorders
Asthenia
|
0.00%
0/18
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
|
Infections and infestations
Cystitis
|
0.00%
0/18
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/18
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/18
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/18
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/18
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/18
|
5.3%
1/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/18
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/18
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Nervous system disorders
Disturbance in attention
|
5.6%
1/18
|
0.00%
0/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
|
Nervous system disorders
Headache
|
5.6%
1/18
|
26.3%
5/19
|
5.3%
1/19
|
5.6%
1/18
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/18
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Nervous system disorders
Presyncope
|
0.00%
0/18
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
|
Nervous system disorders
Somnolence
|
0.00%
0/18
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/18
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/18
|
0.00%
0/19
|
5.3%
1/19
|
0.00%
0/18
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/18
|
5.3%
1/19
|
0.00%
0/19
|
0.00%
0/18
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/18
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/18
|
0.00%
0/19
|
0.00%
0/19
|
5.6%
1/18
|
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