Trial Outcomes & Findings for Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa (NCT NCT02169479)
NCT ID: NCT02169479
Last Updated: 2015-08-17
Results Overview
Levodopa maximum observed plasma concentration (Cmax) (ng/mL)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose
Results posted on
2015-08-17
Participant Flow
Participant milestones
| Measure |
Group 1
Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg
|
Group 2
Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg
|
Group 3
Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg
|
Group 4
Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
4
|
4
|
|
Overall Study
25 mg BIA 9-1067
|
4
|
3
|
4
|
4
|
|
Overall Study
50 mg BIA 9-1067
|
4
|
4
|
4
|
4
|
|
Overall Study
100 mg BIA 9-1067
|
3
|
4
|
4
|
4
|
|
Overall Study
Placebo
|
3
|
3
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Diferente Single Doses of BIA 9-1067 and a Single-dose of Immediate-release 100/25 mg Levodopa/Carbidopa
Baseline characteristics by cohort
| Measure |
Group 1
n=4 Participants
Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg
|
Group 2
n=4 Participants
Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg
|
Group 3
n=4 Participants
Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg
|
Group 4
n=4 Participants
Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg
BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25
BIA 9-1067: OPC, Opicapone
Placebo: PLC, Placebo
Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg
|
Total
n=16 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
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 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
|
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
Male
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-doseLevodopa maximum observed plasma concentration (Cmax) (ng/mL)
Outcome measures
| Measure |
BIA 9-1067 25 mg
n=15 Participants
BIA 9-1067 25 mg OPC Opicapone
|
BIA 9-1067 50 mg
n=16 Participants
BIA 9-1067 50 mg OPC Opicapone
|
BIA 9-1067 100 mg
n=15 Participants
BIA 9-1067 100 mg OPC Opicapone
|
Placebo
n=14 Participants
Placebo, PLC
|
|---|---|---|---|---|
|
Cmax - Maximum Observed Plasma Concentration of Levodopa
|
896 ng/mL
Standard Deviation 300.2
|
1088 ng/mL
Standard Deviation 315.5
|
1014 ng/mL
Standard Deviation 267.7
|
889 ng/mL
Standard Deviation 307.6
|
PRIMARY outcome
Timeframe: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-doseTmax - time of occurrence of Cmax of levodopa.
Outcome measures
| Measure |
BIA 9-1067 25 mg
n=15 Participants
BIA 9-1067 25 mg OPC Opicapone
|
BIA 9-1067 50 mg
n=16 Participants
BIA 9-1067 50 mg OPC Opicapone
|
BIA 9-1067 100 mg
n=15 Participants
BIA 9-1067 100 mg OPC Opicapone
|
Placebo
n=14 Participants
Placebo, PLC
|
|---|---|---|---|---|
|
Tmax - Time of Occurrence of Cmax of Levodopa
|
0.5 hours
Interval 0.5 to 2.0
|
0.5 hours
Interval 0.5 to 3.0
|
0.5 hours
Interval 0.5 to 1.5
|
0.5 hours
Interval 0.5 to 1.5
|
PRIMARY outcome
Timeframe: pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-doseArea under the plasma concentration-time curve for levodopa
Outcome measures
| Measure |
BIA 9-1067 25 mg
n=15 Participants
BIA 9-1067 25 mg OPC Opicapone
|
BIA 9-1067 50 mg
n=16 Participants
BIA 9-1067 50 mg OPC Opicapone
|
BIA 9-1067 100 mg
n=15 Participants
BIA 9-1067 100 mg OPC Opicapone
|
Placebo
n=14 Participants
Placebo, PLC
|
|---|---|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration-time Curve
|
1629 ng.h/mL
Standard Deviation 394.2
|
1727 ng.h/mL
Standard Deviation 405.8
|
1853 ng.h/mL
Standard Deviation 361.3
|
1629 ng.h/mL
Standard Deviation 438.2
|
Adverse Events
BIA 9-1067 25 mg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
BIA 9-1067 50 mg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
BIA 9-1067 100 mg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BIA 9-1067 25 mg
n=15 participants at risk
BIA 9-1067 25 mg OPC Opicapone
|
BIA 9-1067 50 mg
n=16 participants at risk
BIA 9-1067 50 mg OPC Opicapone
|
BIA 9-1067 100 mg
n=15 participants at risk
BIA 9-1067 100 mg OPC Opicapone
|
Placebo
n=14 participants at risk
Placebo, PLC
|
|---|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.00%
0/15
|
6.2%
1/16
|
0.00%
0/15
|
7.1%
1/14
|
|
Eye disorders
Photofobia
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/15
|
7.1%
1/14
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15
|
6.2%
1/16
|
0.00%
0/15
|
7.1%
1/14
|
|
Gastrointestinal disorders
Diarrhoea
|
6.7%
1/15
|
6.2%
1/16
|
0.00%
0/15
|
7.1%
1/14
|
|
Gastrointestinal disorders
Heartburn
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/15
|
7.1%
1/14
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15
|
6.2%
1/16
|
0.00%
0/15
|
0.00%
0/14
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15
|
0.00%
0/16
|
0.00%
0/15
|
0.00%
0/14
|
|
General disorders
Fatigue
|
0.00%
0/15
|
6.2%
1/16
|
0.00%
0/15
|
0.00%
0/14
|
|
General disorders
Vessel puncture site haematoma
|
6.7%
1/15
|
0.00%
0/16
|
0.00%
0/15
|
0.00%
0/14
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/15
|
6.2%
1/16
|
0.00%
0/15
|
0.00%
0/14
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/15
|
0.00%
0/16
|
13.3%
2/15
|
0.00%
0/14
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/15
|
6.2%
1/16
|
0.00%
0/15
|
0.00%
0/14
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/15
|
7.1%
1/14
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/15
|
6.2%
1/16
|
0.00%
0/15
|
0.00%
0/14
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
1/15
|
6.2%
1/16
|
0.00%
0/15
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/15
|
0.00%
0/16
|
6.7%
1/15
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
1/15
|
0.00%
0/16
|
0.00%
0/15
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/15
|
6.2%
1/16
|
0.00%
0/15
|
0.00%
0/14
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/15
|
6.2%
1/16
|
0.00%
0/15
|
0.00%
0/14
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15
|
18.8%
3/16
|
0.00%
0/15
|
0.00%
0/14
|
|
Nervous system disorders
Headache
|
13.3%
2/15
|
12.5%
2/16
|
0.00%
0/15
|
0.00%
0/14
|
|
Nervous system disorders
Somnolence
|
20.0%
3/15
|
12.5%
2/16
|
6.7%
1/15
|
7.1%
1/14
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/15
|
6.2%
1/16
|
0.00%
0/15
|
0.00%
0/14
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/15
|
0.00%
0/16
|
0.00%
0/15
|
7.1%
1/14
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15
|
6.2%
1/16
|
0.00%
0/15
|
0.00%
0/14
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/15
|
0.00%
0/16
|
6.7%
1/15
|
0.00%
0/14
|
|
Vascular disorders
Pallor
|
6.7%
1/15
|
0.00%
0/16
|
0.00%
0/15
|
0.00%
0/14
|
Additional Information
Head of Clinical Research
Bial - Portela & Cª, 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