Trial Outcomes & Findings for Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation (NCT NCT02305329)
NCT ID: NCT02305329
Last Updated: 2015-08-21
Results Overview
Cmax - maximum observed plasma concentration of 9-1067.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dose
Results posted on
2015-08-21
Participant Flow
Participant milestones
| Measure |
Group 1 BIA 9-1067 25 mg
Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC
BIA 9-1067
|
Group 2 BIA 9-1067 25 mg
Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC
BIA 9-1067
|
Group 1 BIA 9-1067 50 mg
Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC
BIA 9-1067
|
Group 2 BIA 9-1067 50 mg
Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC
BIA 9-1067
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
14
|
14
|
|
Overall Study
Period 1
|
14
|
14
|
14
|
14
|
|
Overall Study
Period 2
|
14
|
13
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
13
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Dosage Form Proportionality of Opicapone To-Be-Marketed Formulation
Baseline characteristics by cohort
| Measure |
Group 1 BIA 9-1067 25 mg
n=14 Participants
Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC
BIA 9-1067
|
Group 2 BIA 9-1067 25 mg
n=14 Participants
Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC
BIA 9-1067
|
Group 1 BIA 9-1067 50 mg
n=14 Participants
Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC
BIA 9-1067
|
Group 2 BIA 9-1067 50 mg
n=14 Participants
Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC
BIA 9-1067
|
Total
n=56 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
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
56 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
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC doseCmax - maximum observed plasma concentration of 9-1067.
Outcome measures
| Measure |
5x5mg BIA 9-1067
n=27 Participants
5x5mg BIA 9-1067, OPC
|
1x25 mg BIA 9-1067
n=28 Participants
1x25 mg BIA 9-1067, OPC
|
2x25 mg BIA 9-1067
n=28 Participants
2x25 mg BIA 9-1067, OPC
|
1x50 mg BIA 9-1067
n=28 Participants
1x50 mg BIA 9-1067, OPC
|
|---|---|---|---|---|
|
Cmax - Maximum Observed Plasma Concentration of 9-1067
|
600 ng/mL
Standard Deviation 221
|
567 ng/mL
Standard Deviation 222
|
955 ng/mL
Standard Deviation 297
|
917 ng/mL
Standard Deviation 426
|
SECONDARY outcome
Timeframe: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC dosetmax - time of occurrence of Maximum Observed Plasma Concentration of 9-1067
Outcome measures
| Measure |
5x5mg BIA 9-1067
n=27 Participants
5x5mg BIA 9-1067, OPC
|
1x25 mg BIA 9-1067
n=28 Participants
1x25 mg BIA 9-1067, OPC
|
2x25 mg BIA 9-1067
n=28 Participants
2x25 mg BIA 9-1067, OPC
|
1x50 mg BIA 9-1067
n=28 Participants
1x50 mg BIA 9-1067, OPC
|
|---|---|---|---|---|
|
Tmax - Time of Occurrence of Cmax of 9-1067
|
2.00 hours
Interval 1.0 to 4.0
|
2.00 hours
Interval 1.0 to 4.0
|
2.00 hours
Interval 1.0 to 4.0
|
2.00 hours
Interval 0.5 to 8.0
|
SECONDARY outcome
Timeframe: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC doseOutcome measures
| Measure |
5x5mg BIA 9-1067
n=27 Participants
5x5mg BIA 9-1067, OPC
|
1x25 mg BIA 9-1067
n=28 Participants
1x25 mg BIA 9-1067, OPC
|
2x25 mg BIA 9-1067
n=28 Participants
2x25 mg BIA 9-1067, OPC
|
1x50 mg BIA 9-1067
n=28 Participants
1x50 mg BIA 9-1067, OPC
|
|---|---|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration-time Curve Calculated Between Time of Administration and Time t
|
1603 h.ng/mL
Standard Deviation 566
|
1461 h.ng/mL
Standard Deviation 529
|
2669 h.ng/mL
Standard Deviation 945
|
2539 h.ng/mL
Standard Deviation 1066
|
SECONDARY outcome
Timeframe: before OPC dosing, and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48h post-OPC doseAUC0-∞ - Area under the plasma concentration-time curve extrapolated to infinity.
Outcome measures
| Measure |
5x5mg BIA 9-1067
n=27 Participants
5x5mg BIA 9-1067, OPC
|
1x25 mg BIA 9-1067
n=28 Participants
1x25 mg BIA 9-1067, OPC
|
2x25 mg BIA 9-1067
n=28 Participants
2x25 mg BIA 9-1067, OPC
|
1x50 mg BIA 9-1067
n=28 Participants
1x50 mg BIA 9-1067, OPC
|
|---|---|---|---|---|
|
AUC0-∞ - Area Under the Plasma Concentration-time Curve Extrapolated to Infinity
|
1679 h.ng/mL
Standard Deviation 586
|
1539 h.ng/mL
Standard Deviation 554
|
2699 h.ng/mL
Standard Deviation 1012
|
2612 h.ng/mL
Standard Deviation 1082
|
Adverse Events
5x5mg BIA 9-1067
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
1x25 mg BIA 9-1067
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
2x25 mg BIA 9-1067
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
1x50 mg BIA 9-1067
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
5x5mg BIA 9-1067
n=27 participants at risk
5x5mg BIA 9-1067, OPC
|
1x25 mg BIA 9-1067
n=28 participants at risk
1x25 mg BIA 9-1067, OPC
|
2x25 mg BIA 9-1067
n=28 participants at risk
2x25 mg BIA 9-1067, OPC
|
1x50 mg BIA 9-1067
n=28 participants at risk
1x50 mg BIA 9-1067, OPC
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27
|
7.1%
2/28
|
10.7%
3/28
|
3.6%
1/28
|
|
General disorders
Influenza like illness
|
7.4%
2/27
|
3.6%
1/28
|
3.6%
1/28
|
3.6%
1/28
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/27
|
0.00%
0/28
|
7.1%
2/28
|
0.00%
0/28
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
1/27
|
3.6%
1/28
|
3.6%
1/28
|
10.7%
3/28
|
|
Nervous system disorders
Headache
|
11.1%
3/27
|
17.9%
5/28
|
21.4%
6/28
|
14.3%
4/28
|
|
Nervous system disorders
Somnolence
|
0.00%
0/27
|
7.1%
2/28
|
7.1%
2/28
|
3.6%
1/28
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/27
|
0.00%
0/28
|
3.6%
1/28
|
3.6%
1/28
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/27
|
0.00%
0/28
|
3.6%
1/28
|
3.6%
1/28
|
|
Gastrointestinal disorders
VOMITING
|
3.7%
1/27
|
0.00%
0/28
|
3.6%
1/28
|
3.6%
1/28
|
|
General disorders
CATHETER SITE PAIN
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/28
|
3.6%
1/28
|
|
Infections and infestations
BACTERIAL VAGINOSIS
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/28
|
3.6%
1/28
|
|
Infections and infestations
ORAL HERPES
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/28
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/28
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
3.7%
1/27
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL STIFFNESS
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/28
|
3.6%
1/28
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
0.00%
0/27
|
3.6%
1/28
|
3.6%
1/28
|
0.00%
0/28
|
|
Nervous system disorders
DIZZINESS
|
3.7%
1/27
|
0.00%
0/28
|
0.00%
0/28
|
3.6%
1/28
|
|
Nervous system disorders
TENSION HEADACHE
|
3.7%
1/27
|
0.00%
0/28
|
0.00%
0/28
|
3.6%
1/28
|
|
Reproductive system and breast disorders
DYSMENORRHOEA
|
0.00%
0/27
|
0.00%
0/28
|
0.00%
0/28
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/27
|
3.6%
1/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
ECCHYMOSIS
|
0.00%
0/27
|
3.6%
1/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.00%
0/27
|
3.6%
1/28
|
0.00%
0/28
|
0.00%
0/28
|
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