Trial Outcomes & Findings for A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects (NCT NCT01520727)
NCT ID: NCT01520727
Last Updated: 2015-01-08
Results Overview
Safety was evaluated from the number of reported adverse events (AEs)
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
64 participants
Primary outcome timeframe
7 weeks
Results posted on
2015-01-08
Participant Flow
Participant milestones
| Measure |
BIA 9-1067 10 mg
BIA 9-1067 (Opicapone, OPC) - 10 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 25 mg
BIA 9-1067 (Opicapone, OPC) - 25 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 50 mg
BIA 9-1067 (Opicapone, OPC) - 50 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 100 mg
BIA 9-1067 (Opicapone, OPC) - 100 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 200 mg
BIA 9-1067 (Opicapone, OPC) - 200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 400 mg
BIA 9-1067 (Opicapone, OPC) - 400 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 800 mg
BIA 9-1067 (Opicapone, OPC) - 800 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 1200 mg
BIA 9-1067 (Opicapone, OPC) - 1200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
Placebo
Placebo (PLC): single-dose
Placebo: single-dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
16
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
6
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single Oral Ascending Dose Study of BIA 9-1067 in Healthy Male Subjects
Baseline characteristics by cohort
| Measure |
BIA 9-1067 10 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 10 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 25 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 25 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 50 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 50 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 100 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 100 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 200 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 400 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 400 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 800 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 800 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 1200 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 1200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
Placebo
n=16 Participants
Placebo (PLC): single-dose
Placebo: single-dose
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
6 Participants
n=19 Participants
|
6 Participants
n=147 Participants
|
6 Participants
n=193 Participants
|
16 Participants
|
64 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=147 Participants
|
0 Participants
n=193 Participants
|
0 Participants
|
0 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
6 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=146 Participants
|
6 Participants
n=19 Participants
|
6 Participants
n=147 Participants
|
6 Participants
n=193 Participants
|
16 Participants
|
64 Participants
|
PRIMARY outcome
Timeframe: 7 weeksSafety was evaluated from the number of reported adverse events (AEs)
Outcome measures
| Measure |
BIA 9-1067 10 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 10 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 25 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 25 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 50 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 50 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 100 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 100 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 200 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 400 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 400 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 800 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 800 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 1200 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 1200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
Placebo
n=16 Participants
Placebo (PLC): single-dose
Placebo: single-dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Adverse Events (AEs)
|
0 Number of Adverse Events
|
0 Number of Adverse Events
|
2 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
1 Number of Adverse Events
|
0 Number of Adverse Events
|
1 Number of Adverse Events
|
4 Number of Adverse Events
|
SECONDARY outcome
Timeframe: pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post doseCmax - maximum plasma concentration
Outcome measures
| Measure |
BIA 9-1067 10 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 10 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 25 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 25 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 50 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 50 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 100 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 100 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 200 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 400 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 400 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 800 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 800 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 1200 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 1200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
Placebo
Placebo (PLC): single-dose
Placebo: single-dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax - BIA 9-1067
|
130.7 ng/mL
Standard Deviation 68.0
|
308.5 ng/mL
Standard Deviation 128.1
|
522.2 ng/mL
Standard Deviation 186.7
|
927.2 ng/mL
Standard Deviation 378.9
|
1287.5 ng/mL
Standard Deviation 585.6
|
2013.3 ng/mL
Standard Deviation 608.7
|
2786.7 ng/mL
Standard Deviation 1335.9
|
4883.3 ng/mL
Standard Deviation 1501.5
|
—
|
SECONDARY outcome
Timeframe: pre-dose then post-dose. Hour 0.25, 0.5, 0,75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 36, 48 , 60 and 72 hours post doseOutcome measures
| Measure |
BIA 9-1067 10 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 10 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 25 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 25 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 50 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 50 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 100 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 100 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 200 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 400 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 400 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 800 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 800 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 1200 mg
n=6 Participants
BIA 9-1067 (Opicapone, OPC) - 1200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
Placebo
Placebo (PLC): single-dose
Placebo: single-dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Time to Cmax (Tmax)
|
2.5 hours
Interval 2.0 to 4.0
|
1.5 hours
Interval 1.0 to 4.0
|
3.5 hours
Interval 1.5 to 4.0
|
1.8 hours
Interval 1.0 to 3.0
|
2.0 hours
Interval 1.0 to 3.0
|
2.0 hours
Interval 1.5 to 5.0
|
2.5 hours
Interval 0.8 to 5.3
|
1.5 hours
Interval 1.0 to 3.0
|
—
|
Adverse Events
BIA 9-1067 10 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BIA 9-1067 25 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BIA 9-1067 50 mg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
BIA 9-1067 100 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BIA 9-1067 200 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BIA 9-1067 400 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BIA 9-1067 800 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
BIA 9-1067 1200 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BIA 9-1067 10 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 10 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 25 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 25 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 50 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 50 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 100 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 100 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 200 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 400 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 400 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 800 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 800 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 1200 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 1200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
Placebo
n=16 participants at risk
Placebo (PLC): single-dose
Placebo: single-dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Spastic Paraplegia
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
BIA 9-1067 10 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 10 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 25 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 25 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 50 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 50 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 100 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 100 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 200 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 400 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 400 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 800 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 800 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
BIA 9-1067 1200 mg
n=6 participants at risk
BIA 9-1067 (Opicapone, OPC) - 1200 mg
BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
|
Placebo
n=16 participants at risk
Placebo (PLC): single-dose
Placebo: single-dose
|
|---|---|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Syncope Vasovagal
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/16
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/16
|
|
Nervous system disorders
Headache
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/16
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/16
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
6.2%
1/16
|
|
Vascular disorders
Orthostatic Hypotension
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
6.2%
1/16
|
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