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Single-centre, open-label, randomised, three-part, two-way crossover study in 84 healthy volunteers. In each part, the study consisted of two consecutive single-dose treatment periods separated by a washout period of at least 14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIA 9-1067 5 mg Sequence 1 | Experimental | 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 25 mg Sequence 1 | Experimental | 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 50 mg Sequence 1 | Experimental | 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 5 mg Sequence 2 | Experimental | 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 25 mg Sequence 2 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIA 9-1067 (clinical micronized, CM) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax - Maximum Observed Plasma Concentration | before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-t - Area Under the Plasma Concentration-time Curve for BIA 9-1067 | Area Under the plasma concentration-time Curve from time 0 to the time of last quantifiable concentration | before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose |
| Tmax - Time of Occurrence of Cmax |
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Inclusion Criteria:
Exclusion Criteria:
If female:
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| ID | Title | Description |
|---|---|---|
| FG000 | 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) |
| FG001 | 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) |
| FG002 | 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) |
| FG003 | 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) |
| FG004 | 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) |
| FG005 | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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) |
| BG001 | BIA 9-1067 25 mg Sequence 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cmax - Maximum Observed Plasma Concentration | Posted | Mean | Standard Deviation | ng/mL | before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BIA 9-1067 5 mg CM | BIA 9-1067 5 mg CM CM - clinical micronized |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (17.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (17.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Research | Bial - Portela & Cª, S.A. | +351 229 866 100 | jose.rocha@bial.com |
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| ID | Term |
|---|---|
| C549349 | opicapone |
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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 50 mg Sequence 2 | Experimental | 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 (to-be-marketed, TBM) | Drug |
|
|
| before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose |
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) |
| BG002 | 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) |
| BG003 | 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) |
| BG004 | 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) |
| BG005 | 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) |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG003 |
| BIA 9-1067 25 mg TBM |
BIA 9-1067 25 mg TBM TBM - to-be-marketed |
| OG004 | BIA 9-1067 50 mg CM | BIA 9-1067 50 mg CM CM - clinical micronized |
| OG005 | BIA 9-1067 50 mg TBM | BIA 9-1067 50 mg TBM TBM - to-be-marketed |
|
|
| Secondary | AUC0-t - Area Under the Plasma Concentration-time Curve for BIA 9-1067 | Area Under the plasma concentration-time Curve from time 0 to the time of last quantifiable concentration | Posted | Mean | Standard Deviation | ng.h/mL | before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose |
|
|
|
| Secondary | Tmax - Time of Occurrence of Cmax | Posted | Median | Full Range | hours | before OPC dosing, and ½, 1, 2, 3, 4, 6, 8, 12, 16, 24, 36 and 48 hours post-OPC dose |
|
|
|
| 0 |
| 29 |
| 1 |
| 29 |
| EG001 | BIA 9-1067 5 mg TBM | BIA 9-1067 5 mg TBM TBM - to-be-marketed | 0 | 28 | 3 | 28 |
| EG002 | BIA 9-1067 25 mg CM | BIA 9-1067 25 mg CM CM - clinical micronized | 1 | 28 | 6 | 28 |
| EG003 | BIA 9-1067 25 mg TBM | BIA 9-1067 25 mg TBM TBM - to-be-marketed | 0 | 28 | 3 | 28 |
| EG004 | BIA 9-1067 50 mg CM | BIA 9-1067 50 mg CM CM - clinical micronized | 0 | 28 | 1 | 28 |
| EG005 | BIA 9-1067 50 mg TBM | BIA 9-1067 50 mg TBM TBM - to-be-marketed | 0 | 28 | 3 | 28 |
| Conjunctivitis | Infections and infestations | MedDRA (17.0) |
|
| Headache | Nervous system disorders | MedDRA (17.0) |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) |
|
| Nasopharyngitis | Infections and infestations | MedDRA (17.0) |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA (17.0) |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) |
|
| Dizziness postural | Nervous system disorders | MedDRA (17.0) |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA (17.0) |
|
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