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To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of immediate-release levodopa/benserazide 100/25 mg (Prolopa® 100-25)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo Every period with concomitant single oral administration of Prolopa® 100-25 |
|
| Group 2 | Experimental | Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg Every period with concomitant single oral administration of Prolopa® 100-25 |
|
| Group 3 | Experimental | Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg Every period with concomitant single oral administration of Prolopa® 100-25 |
|
| Group 4 | Active Comparator | Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg Every period with concomitant single oral administration of Prolopa® 100-25 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIA 9-1067 | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Drug Concentration (Cmax) | Cmax - Maximum observed plasma drug concentration of benserazide | pre-dose, 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose |
| Tmax - Time of Occurrence of Cmax | tmax - time of occurrence of Cmax of benserazide | pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose |
| AUC0-t - Area Under the Plasma Concentration-time Curve | AUC0-t - area under the plasma concentration-time curve of benserazide. | pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Algorithme Pharma Inc | Mount Royal | Quebec | H3P 3P1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo Every period with concomitant single oral administration of Prolopa® 100-25 Prolopa®: levodopa/benserazide 100/25 mg |
| FG001 | Group 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo |
| Drug |
|
|
| Prolopa® | Drug | levodopa/benserazide 100/25 mg |
|
|
Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg Every period with concomitant single oral administration of Prolopa® 100-25 Prolopa®: levodopa/benserazide 100/25 mg |
| FG002 | Group 3 | Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg Every period with concomitant single oral administration of Prolopa® 100-25 Prolopa®: levodopa/benserazide 100/25 mg |
| FG003 | Group 4 | Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg Every period with concomitant single oral administration of Prolopa® 100-25 Prolopa®: levodopa/benserazide 100/25 mg |
| 25 mg BIA 9-1067 |
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| 50 mg BIA 9-1067 |
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| 100 mg BIA 9-1067 |
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| Placebo |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo Every period with concomitant single oral administration of Prolopa® 100-25 |
| BG001 | Group 2 | Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg Every period with concomitant single oral administration of Prolopa® 100-25 |
| BG002 | Group 3 | Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg Every period with concomitant single oral administration of Prolopa® 100-25 |
| BG003 | Group 4 | Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg Every period with concomitant single oral administration of Prolopa® 100-25 |
| BG004 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Maximum Observed Plasma Drug Concentration (Cmax) | Cmax - Maximum observed plasma drug concentration of benserazide | Posted | Mean | Standard Deviation | ng/mL | pre-dose, 0.5,1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose |
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| Primary | Tmax - Time of Occurrence of Cmax | tmax - time of occurrence of Cmax of benserazide | Posted | Median | Full Range | hours | pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose |
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| Primary | AUC0-t - Area Under the Plasma Concentration-time Curve | AUC0-t - area under the plasma concentration-time curve of benserazide. | Posted | Mean | Standard Deviation | ng.h/mL | pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-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 25 mg Group | BIA 9-1067 25 mg Group. with concomitant single oral administration of Prolopa® 100-25 | 0 | 16 | 10 | 16 | ||
| EG001 | BIA 9-1067 50 mg Group | BIA 9-1067 50 mg Group. with concomitant single oral administration of Prolopa® 100-25 | 0 | 16 | 10 | 16 | ||
| EG002 | BIA 9-1067 100 mg Group | BIA 9-1067 100 mg Group. with concomitant single oral administration of Prolopa® 100-25 | 0 | 14 | 9 | 14 | ||
| EG003 | Placebo Group | Placebo Group. with concomitant single oral administration of Prolopa® 100-25 | 0 | 16 | 6 | 16 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia supraventricular | Cardiac disorders | MedDRA (10.0) |
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| Atrioventricular block first degree | Cardiac disorders | MedDRA (10.0) |
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| Vertigo | Ear and labyrinth disorders | MedDRA (10.0) |
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| Ocular hyperaemia | Eye disorders | MedDRA (10.0) |
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| Abdominal distension | Gastrointestinal disorders | MedDRA (10.0) |
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| Abdominal pain | Gastrointestinal disorders | MedDRA (10.0) |
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| Constipation | Gastrointestinal disorders | MedDRA (10.0) |
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| Dry mouth | Gastrointestinal disorders | MedDRA (10.0) |
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| Nausea | Gastrointestinal disorders | MedDRA (10.0) |
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| Vomiting | Gastrointestinal disorders | MedDRA (10.0) |
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| Fatigue | General disorders | MedDRA (10.0) |
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| Feeling cold | General disorders | MedDRA (10.0) |
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| Venipuncture site swelling | General disorders | MedDRA (10.0) |
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| Vessel puncture site reaction | General disorders | MedDRA (10.0) |
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| Upper respiratory tract infection | Infections and infestations | MedDRA (10.0) |
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| Skin laceration | Injury, poisoning and procedural complications | MedDRA (10.0) |
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| Thermal burn | Injury, poisoning and procedural complications | MedDRA (10.0) |
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| Aspartate aminotransferase increased | Investigations | MedDRA (10.0) |
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| Blood creatine phosphokinase increased | Investigations | MedDRA (10.0) |
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| Blood glucose decreased | Investigations | MedDRA (10.0) |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (10.0) |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) |
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| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (10.0) |
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| Weakness in extremity | Musculoskeletal and connective tissue disorders | MedDRA (10.0) |
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| Balance disorder | Nervous system disorders | MedDRA (10.0) |
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| Dizziness | Nervous system disorders | MedDRA (10.0) |
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| Dysgeusia | Nervous system disorders | MedDRA (10.0) |
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| Headache | Nervous system disorders | MedDRA (10.0) |
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| Somnolence | Nervous system disorders | MedDRA (10.0) |
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| Tremor | Nervous system disorders | MedDRA (10.0) |
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| Anxiety | Psychiatric disorders | MedDRA (10.0) |
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| Insomnia | Psychiatric disorders | MedDRA (10.0) |
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| Proteinuria | Renal and urinary disorders | MedDRA (10.0) |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) |
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| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) |
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| Nasal dryness | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) |
| ||
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) |
| ||
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) |
| ||
| Flushing | Vascular disorders | MedDRA (10.0) |
|
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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 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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| ID | Term |
|---|---|
| C549349 | opicapone |
| C005177 | benserazide, levodopa drug combination |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Participants |
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| Participants |
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