Trial Outcomes & Findings for Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers (NCT NCT02305277)
NCT ID: NCT02305277
Last Updated: 2025-03-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
85 participants
Primary outcome timeframe
before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose
Results posted on
2025-03-12
Participant Flow
Participant milestones
| Measure |
BIA 9-1067 5 mg Sequence 1
volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)
|
BIA 9-1067 25 mg Sequence 1
volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)
|
BIA 9-1067 50 mg Sequence 1
volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)
|
BIA 9-1067 5 mg Sequence 2
volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)
|
BIA 9-1067 25 mg Sequence 2
volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)
|
BIA 9-1067 50 mg Sequence 2
volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
14
|
14
|
14
|
14
|
14
|
|
Overall Study
Received CM
|
15
|
14
|
14
|
14
|
14
|
14
|
|
Overall Study
Received TBM
|
15
|
14
|
14
|
14
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
14
|
14
|
14
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Relative Bioavailability and Bioequivalence Of Different Formulations of Opicapone in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
BIA 9-1067 5 mg Sequence 1
n=15 Participants
volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)
|
BIA 9-1067 25 mg Sequence 1
n=14 Participants
volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)
|
BIA 9-1067 50 mg Sequence 1
n=14 Participants
volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)
|
BIA 9-1067 5 mg Sequence 2
n=14 Participants
volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)
|
BIA 9-1067 25 mg Sequence 2
n=14 Participants
volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)
|
BIA 9-1067 50 mg Sequence 2
n=14 Participants
volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation
CM - clinical micronized TBM - to-be-marketed
BIA 9-1067 (clinical micronized, CM)
BIA 9-1067 (to-be-marketed, TBM)
|
Total
n=85 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
85 Participants
n=8 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
37 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC doseOutcome measures
| Measure |
BIA 9-1067 5 mg CM
n=29 Participants
BIA 9-1067 5 mg CM CM - clinical micronized
|
BIA 9-1067 5 mg TBM
n=28 Participants
BIA 9-1067 5 mg TBM TBM - to-be-marketed
|
BIA 9-1067 25 mg CM
n=28 Participants
BIA 9-1067 25 mg CM CM - clinical micronized
|
BIA 9-1067 25 mg TBM
n=28 Participants
BIA 9-1067 25 mg TBM TBM - to-be-marketed
|
BIA 9-1067 50 mg CM
n=28 Participants
BIA 9-1067 50 mg CM CM - clinical micronized
|
BIA 9-1067 50 mg TBM
n=28 Participants
BIA 9-1067 50 mg TBM TBM - to-be-marketed
|
|---|---|---|---|---|---|---|
|
Cmax - Maximum Observed Plasma Concentration
|
107.3 ng/mL
Standard Deviation 55.7
|
95.5 ng/mL
Standard Deviation 37.8
|
424.5 ng/mL
Standard Deviation 155.7
|
471.0 ng/mL
Standard Deviation 206.9
|
756.2 ng/mL
Standard Deviation 302.4
|
802.9 ng/mL
Standard Deviation 363.0
|
SECONDARY outcome
Timeframe: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC doseArea Under the plasma concentration-time Curve from time 0 to the time of last quantifiable concentration
Outcome measures
| Measure |
BIA 9-1067 5 mg CM
n=29 Participants
BIA 9-1067 5 mg CM CM - clinical micronized
|
BIA 9-1067 5 mg TBM
n=28 Participants
BIA 9-1067 5 mg TBM TBM - to-be-marketed
|
BIA 9-1067 25 mg CM
n=28 Participants
BIA 9-1067 25 mg CM CM - clinical micronized
|
BIA 9-1067 25 mg TBM
n=28 Participants
BIA 9-1067 25 mg TBM TBM - to-be-marketed
|
BIA 9-1067 50 mg CM
n=28 Participants
BIA 9-1067 50 mg CM CM - clinical micronized
|
BIA 9-1067 50 mg TBM
n=28 Participants
BIA 9-1067 50 mg TBM TBM - to-be-marketed
|
|---|---|---|---|---|---|---|
|
AUC0-t - Area Under the Plasma Concentration-time Curve for BIA 9-1067
|
196.8 ng.h/mL
Standard Deviation 128.5
|
197.7 ng.h/mL
Standard Deviation 89.7
|
1137 ng.h/mL
Standard Deviation 413.8
|
1270 ng.h/mL
Standard Deviation 515.5
|
2043 ng.h/mL
Standard Deviation 1032
|
2161 ng.h/mL
Standard Deviation 1110
|
SECONDARY outcome
Timeframe: before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC doseOutcome measures
| Measure |
BIA 9-1067 5 mg CM
n=29 Participants
BIA 9-1067 5 mg CM CM - clinical micronized
|
BIA 9-1067 5 mg TBM
n=28 Participants
BIA 9-1067 5 mg TBM TBM - to-be-marketed
|
BIA 9-1067 25 mg CM
n=28 Participants
BIA 9-1067 25 mg CM CM - clinical micronized
|
BIA 9-1067 25 mg TBM
n=28 Participants
BIA 9-1067 25 mg TBM TBM - to-be-marketed
|
BIA 9-1067 50 mg CM
n=28 Participants
BIA 9-1067 50 mg CM CM - clinical micronized
|
BIA 9-1067 50 mg TBM
n=28 Participants
BIA 9-1067 50 mg TBM TBM - to-be-marketed
|
|---|---|---|---|---|---|---|
|
Tmax - Time of Occurrence of Cmax
|
2.00 hours
Interval 0.5 to 4.0
|
1.00 hours
Interval 0.5 to 4.0
|
2.00 hours
Interval 0.5 to 4.0
|
2.00 hours
Interval 0.5 to 4.0
|
2.00 hours
Interval 1.0 to 4.0
|
2.00 hours
Interval 1.0 to 4.0
|
Adverse Events
BIA 9-1067 5 mg CM
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BIA 9-1067 5 mg TBM
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BIA 9-1067 25 mg CM
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
BIA 9-1067 25 mg TBM
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
BIA 9-1067 50 mg CM
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
BIA 9-1067 50 mg TBM
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BIA 9-1067 5 mg CM
n=29 participants at risk
BIA 9-1067 5 mg CM CM - clinical micronized
|
BIA 9-1067 5 mg TBM
n=28 participants at risk
BIA 9-1067 5 mg TBM TBM - to-be-marketed
|
BIA 9-1067 25 mg CM
n=28 participants at risk
BIA 9-1067 25 mg CM CM - clinical micronized
|
BIA 9-1067 25 mg TBM
n=28 participants at risk
BIA 9-1067 25 mg TBM TBM - to-be-marketed
|
BIA 9-1067 50 mg CM
n=28 participants at risk
BIA 9-1067 50 mg CM CM - clinical micronized
|
BIA 9-1067 50 mg TBM
n=28 participants at risk
BIA 9-1067 50 mg TBM TBM - to-be-marketed
|
|---|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/29
|
0.00%
0/28
|
3.6%
1/28
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
Other adverse events
| Measure |
BIA 9-1067 5 mg CM
n=29 participants at risk
BIA 9-1067 5 mg CM CM - clinical micronized
|
BIA 9-1067 5 mg TBM
n=28 participants at risk
BIA 9-1067 5 mg TBM TBM - to-be-marketed
|
BIA 9-1067 25 mg CM
n=28 participants at risk
BIA 9-1067 25 mg CM CM - clinical micronized
|
BIA 9-1067 25 mg TBM
n=28 participants at risk
BIA 9-1067 25 mg TBM TBM - to-be-marketed
|
BIA 9-1067 50 mg CM
n=28 participants at risk
BIA 9-1067 50 mg CM CM - clinical micronized
|
BIA 9-1067 50 mg TBM
n=28 participants at risk
BIA 9-1067 50 mg TBM TBM - to-be-marketed
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/29
|
3.6%
1/28
|
0.00%
0/28
|
3.6%
1/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/29
|
3.6%
1/28
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Nervous system disorders
Headache
|
3.4%
1/29
|
7.1%
2/28
|
7.1%
2/28
|
3.6%
1/28
|
0.00%
0/28
|
7.1%
2/28
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/29
|
0.00%
0/28
|
0.00%
0/28
|
3.6%
1/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/29
|
0.00%
0/28
|
3.6%
1/28
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/29
|
0.00%
0/28
|
3.6%
1/28
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/29
|
0.00%
0/28
|
3.6%
1/28
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/29
|
0.00%
0/28
|
0.00%
0/28
|
3.6%
1/28
|
0.00%
0/28
|
3.6%
1/28
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/29
|
0.00%
0/28
|
0.00%
0/28
|
7.1%
2/28
|
0.00%
0/28
|
3.6%
1/28
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/29
|
0.00%
0/28
|
7.1%
2/28
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/29
|
0.00%
0/28
|
0.00%
0/28
|
0.00%
0/28
|
3.6%
1/28
|
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