Trial Outcomes & Findings for A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067 (NCT NCT01568034)
NCT ID: NCT01568034
Last Updated: 2015-01-12
Results Overview
Cmax - Maximum plasma concentration (ng/mL)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
Day 3
Results posted on
2015-01-12
Participant Flow
Participant milestones
| Measure |
Treatment Sequence A
Period 1 - 25 mg BIA 9-1067 Period 2 - 50 mg BIA 9-1067 Period 3 - 100 mg BIA 9-1067 Period 4 - Placebo
Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
|
Treatment Sequence B
Treatment Sequence B Period 1 - Placebo Period 2 - 25 mg BIA 9-1067 Period 3 - 50 mg BIA 9-1067 Period 4 - 100 mg BIA 9-1067
Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
|
Treatment Sequence C
Treatment Sequence C Period 1 - 100 mg BIA 9-1067 Period 2 - Placebo Period 3 - 25 mg BIA 9-1067 Period 4 - 50 mg BIA 9-1067
Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
|
Treatment Sequence D
Treatment Sequence D Period 1 - 50 mg BIA 9-1067 Period 2 - 100 mg BIA 9-1067 Period 3 - Placebo Period 4 - 25 mg BIA 9-1067
Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
3
|
3
|
|
Overall Study
25 mg BIA 9-1067
|
2
|
2
|
3
|
3
|
|
Overall Study
50 mg BIA 9-1067
|
2
|
2
|
3
|
3
|
|
Overall Study
100 mg BIA 9-1067
|
2
|
2
|
3
|
3
|
|
Overall Study
Placebo
|
1
|
2
|
3
|
3
|
|
Overall Study
COMPLETED
|
1
|
2
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Treatment Sequence A
Period 1 - 25 mg BIA 9-1067 Period 2 - 50 mg BIA 9-1067 Period 3 - 100 mg BIA 9-1067 Period 4 - Placebo
Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
|
Treatment Sequence B
Treatment Sequence B Period 1 - Placebo Period 2 - 25 mg BIA 9-1067 Period 3 - 50 mg BIA 9-1067 Period 4 - 100 mg BIA 9-1067
Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
|
Treatment Sequence C
Treatment Sequence C Period 1 - 100 mg BIA 9-1067 Period 2 - Placebo Period 3 - 25 mg BIA 9-1067 Period 4 - 50 mg BIA 9-1067
Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
|
Treatment Sequence D
Treatment Sequence D Period 1 - 50 mg BIA 9-1067 Period 2 - 100 mg BIA 9-1067 Period 3 - Placebo Period 4 - 25 mg BIA 9-1067
Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study to Investigate the Tolerability and Effect of Three Single-dose Regimens of BIA 9-1067
Baseline characteristics by cohort
| Measure |
Overall Study
n=10 Participants
The study was to consist of four consecutive treatment periods, corresponding to the 4 different treatment options (25 mg, 50 mg and 100 mg BIA 9-1067or Placebo).According to randomisation, subjects were to receive, in a double-blind manner, 25, 50 and 100 mg BIA 9-1067 or Placebo at 4 separate treatment periods. Each subject were to receive each of the three BIA 9-1067 doses and Placebo in a random sequence with a 3:1 ratio (BIA 9-1067: Placebo) per treatment period.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 3Cmax - Maximum plasma concentration (ng/mL)
Outcome measures
| Measure |
Placebo
n=9 Participants
PLC, Placebo
|
BIA 9-1067 25 mg
n=10 Participants
BIA 9-1067 - OPC, Opicapone
|
BIA 9-1067 50 mg
n=10 Participants
BIA 9-1067 - OPC, Opicapone
|
BIA 9-1067 100 mg
n=10 Participants
BIA 9-1067 - OPC, Opicapone
|
|---|---|---|---|---|
|
Cmax - Maximum Plasma Concentration Day 3
Cmax (levodopa)
|
2103 ng/ml
Standard Deviation 48.4
|
2112 ng/ml
Standard Deviation 49.6
|
2366 ng/ml
Standard Deviation 44.0
|
2657 ng/ml
Standard Deviation 32.5
|
|
Cmax - Maximum Plasma Concentration Day 3
Cmax (3-OMD)
|
3996 ng/ml
Standard Deviation 50.5
|
4193 ng/ml
Standard Deviation 42.4
|
4284 ng/ml
Standard Deviation 49.2
|
4085 ng/ml
Standard Deviation 60.4
|
|
Cmax - Maximum Plasma Concentration Day 3
Cmax (BIA 9-067)
|
NA ng/ml
Standard Deviation NA
BIA 9-067 was not administered
|
320 ng/ml
Standard Deviation 57.2
|
590 ng/ml
Standard Deviation 41.5
|
816 ng/ml
Standard Deviation 35.5
|
PRIMARY outcome
Timeframe: Day 3tmax = time to Cmax (values are median)
Outcome measures
| Measure |
Placebo
n=9 Participants
PLC, Placebo
|
BIA 9-1067 25 mg
n=10 Participants
BIA 9-1067 - OPC, Opicapone
|
BIA 9-1067 50 mg
n=10 Participants
BIA 9-1067 - OPC, Opicapone
|
BIA 9-1067 100 mg
n=10 Participants
BIA 9-1067 - OPC, Opicapone
|
|---|---|---|---|---|
|
Tmax = Time to Cmax Day 3
Tmax (levodopa)
|
0.5 hours
Interval 0.5 to 1.5
|
1.0 hours
Interval 0.5 to 2.0
|
0.5 hours
Interval 0.5 to 2.0
|
0.5 hours
Interval 0.5 to 1.5
|
|
Tmax = Time to Cmax Day 3
Tmax (3-OMD)
|
2.00 hours
Interval 0.0 to 3.0
|
1.75 hours
Interval 0.0 to 4.0
|
2.50 hours
Interval 0.0 to 4.0
|
1.75 hours
Interval 1.0 to 6.0
|
|
Tmax = Time to Cmax Day 3
Tmax (BIA 9-067)
|
NA hours
BIA 9-067 was not administered
|
2.00 hours
Interval 0.5 to 3.0
|
2.00 hours
Interval 1.0 to 6.0
|
2.00 hours
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 3AUC0-6 - area under the plasma concentration-time curve from time 0 to 6 hours post-dose (ng.h/mL)
Outcome measures
| Measure |
Placebo
n=9 Participants
PLC, Placebo
|
BIA 9-1067 25 mg
n=10 Participants
BIA 9-1067 - OPC, Opicapone
|
BIA 9-1067 50 mg
n=10 Participants
BIA 9-1067 - OPC, Opicapone
|
BIA 9-1067 100 mg
n=10 Participants
BIA 9-1067 - OPC, Opicapone
|
|---|---|---|---|---|
|
AUC0-6 - Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours Post-dose (Day 3)
AUC0-6 (levodopa)
|
3958 ng.h/mL
Standard Deviation 46.7
|
4545 ng.h/mL
Standard Deviation 61.4
|
4580 ng.h/mL
Standard Deviation 36.5
|
5440 ng.h/mL
Standard Deviation 46.4
|
|
AUC0-6 - Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours Post-dose (Day 3)
AUC0-6 (3-OMD)
|
22334 ng.h/mL
Standard Deviation 51.1
|
22026 ng.h/mL
Standard Deviation 44.3
|
23515 ng.h/mL
Standard Deviation 50.0
|
22200 ng.h/mL
Standard Deviation 61.4
|
|
AUC0-6 - Area Under the Plasma Concentration-time Curve From Time 0 to 6 Hours Post-dose (Day 3)
AUC0-6 (BIA 9-1067)
|
NA ng.h/mL
Standard Deviation NA
BIA 9-067 was not administered
|
776 ng.h/mL
Standard Deviation 60.1
|
1694 ng.h/mL
Standard Deviation 34.6
|
2647 ng.h/mL
Standard Deviation 51.4
|
Adverse Events
25 mg BIA 9-1067
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
50 mg BIA 9-1067
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
100 mg BIA 9-1067
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
25 mg BIA 9-1067
n=10 participants at risk
25 mg BIA 9-1067 ESL, Eslicarbazepine
|
50 mg BIA 9-1067
n=10 participants at risk
50 mg BIA 9-1067 ESL, Eslicarbazepine
|
100 mg BIA 9-1067
n=10 participants at risk
100 mg BIA 9-1067 ESL, Eslicarbazepine
|
Placebo
n=9 participants at risk
Placebo ESL, Eslicarbazepine
|
|---|---|---|---|---|
|
Investigations
EOSINOPHIL PERCENTAGE INCREASED
|
0.00%
0/10 • 10 months
|
10.0%
1/10 • 10 months
|
10.0%
1/10 • 10 months
|
11.1%
1/9 • 10 months
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/10 • 10 months
|
10.0%
1/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/9 • 10 months
|
|
Blood and lymphatic system disorders
ANAEMIA
|
10.0%
1/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/9 • 10 months
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/10 • 10 months
|
10.0%
1/10 • 10 months
|
10.0%
1/10 • 10 months
|
11.1%
1/9 • 10 months
|
|
Cardiac disorders
SUPRAVENTRICULAR EXTRASYSTOLES
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
10.0%
1/10 • 10 months
|
0.00%
0/9 • 10 months
|
|
Infections and infestations
INFLUENZA
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
10.0%
1/10 • 10 months
|
0.00%
0/9 • 10 months
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
11.1%
1/9 • 10 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
11.1%
1/9 • 10 months
|
|
Vascular disorders
PALLOR
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
11.1%
1/9 • 10 months
|
|
Infections and infestations
RESPIRATORY INFECTION
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
11.1%
1/9 • 10 months
|
|
General disorders
OEDEMA PERIPHERAL
|
10.0%
1/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/9 • 10 months
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
10.0%
1/10 • 10 months
|
0.00%
0/9 • 10 months
|
|
Nervous system disorders
HEADACHE
|
10.0%
1/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/9 • 10 months
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/10 • 10 months
|
10.0%
1/10 • 10 months
|
10.0%
1/10 • 10 months
|
0.00%
0/9 • 10 months
|
|
Psychiatric disorders
HALLUCINATION
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
11.1%
1/9 • 10 months
|
|
Investigations
BLOOD PRESSURE INCREASED
|
0.00%
0/10 • 10 months
|
10.0%
1/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/9 • 10 months
|
|
Nervous system disorders
LIGHTHEADEDNESS
|
0.00%
0/10 • 10 months
|
10.0%
1/10 • 10 months
|
10.0%
1/10 • 10 months
|
0.00%
0/9 • 10 months
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
10.0%
1/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/9 • 10 months
|
|
Ear and labyrinth disorders
VERTIGO
|
0.00%
0/10 • 10 months
|
10.0%
1/10 • 10 months
|
10.0%
1/10 • 10 months
|
0.00%
0/9 • 10 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
10.0%
1/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/9 • 10 months
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/10 • 10 months
|
10.0%
1/10 • 10 months
|
0.00%
0/10 • 10 months
|
0.00%
0/9 • 10 months
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/10 • 10 months
|
0.00%
0/10 • 10 months
|
10.0%
1/10 • 10 months
|
0.00%
0/9 • 10 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER