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The purpose of this study is to investigate the effect of BIA 9-1067 on rasagiline pharmacokinetics in healthy subjects.
Single-centre, open-label, randomised, three-way crossover study consisting of 3 single-dose periods separated by a washout of 14 days or more
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg |
|
| Group 2 | Experimental | Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg |
|
| Group 3 | Experimental | Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| rasagiline | Drug | 1 mg rasagiline (single-dose) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax - Maximum Observed Plasma Concentration | pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax - Time of Occurrence of Cmax | pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose | |
| AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration | pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Béatric Astruc, MD | Biotrial - Human Pharmacology Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BIOTRIAL | Rennes | F-35000 | France |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg rasagiline: 1 mg rasagiline (single-dose) BIA 9-1067: 50 mg BIA 9-1067 (single-dose) |
| FG001 | Group 2 | Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg rasagiline: 1 mg rasagiline (single-dose) BIA 9-1067: 50 mg BIA 9-1067 (single-dose) |
| FG002 | Group 3 | Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg rasagiline: 1 mg rasagiline (single-dose) BIA 9-1067: 50 mg BIA 9-1067 (single-dose) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg rasagiline: 1 mg rasagiline (single-dose) BIA 9-1067: 50 mg BIA 9-1067 (single-dose) |
| BG001 | Group 2 |
| 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 | pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 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 | Before Treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders |
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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 |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C031967 | rasagiline |
| C549349 | opicapone |
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| BIA 9-1067 |
| Drug |
50 mg BIA 9-1067 (single-dose) |
|
Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg rasagiline: 1 mg rasagiline (single-dose) BIA 9-1067: 50 mg BIA 9-1067 (single-dose) |
| BG002 | Group 3 | Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg rasagiline: 1 mg rasagiline (single-dose) BIA 9-1067: 50 mg BIA 9-1067 (single-dose) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Tmax - Time of Occurrence of Cmax | Posted | Median | Full Range | hours | pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose |
|
|
|
| Secondary | AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration | Posted | Mean | Standard Deviation | ng.h/mL | pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose |
|
|
|
| 0 |
| 24 |
| 1 |
| 24 |
| EG001 | Rasagiline Alone | 0 | 24 | 6 | 24 |
| EG002 | Rasagiline 1 h After BIA 9-1067 | 0 | 24 | 3 | 24 |
| EG003 | Rasagiline Concomitant BIA 9-1067 | 0 | 24 | 3 | 24 |
| Influenza like illness | General disorders |
|
| Pharyngitis | Infections and infestations |
|
| Blood creatine phosphokinase increased | Investigations |
|
| Headache | Nervous system disorders |
|
| Sciatica | Nervous system disorders |
|
| Dysmenorrhoea | Reproductive system and breast disorders |
|
| Erythema | Skin and subcutaneous tissue disorders |
|
| Pruritus | Skin and subcutaneous tissue disorders |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| Rasagiline |
|
|