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To determine the absorption, metabolism and excretion of BIA 9-1067.
Monocentre, open, non-placebo-controlled, single-group, single-dose study
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIA 9-1067 | Experimental | 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIA 9-1067 | Drug | 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites | 24 hours:pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach Maximum Plasma Concentration (Tmax) | Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites | 24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seiberling Michael, MD | Covance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Basel Research Unit AG (formerly Swiss Pharma Contract Ltd) | Allschwil | Base | CH-4123 | Switzerland |
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| ID | Title | Description |
|---|---|---|
| FG000 | BIA 9-1067 | 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose). BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BIA 9-1067 | 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose). BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose). |
| 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 | Maximum Plasma Concentration (Cmax) | Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites | Posted | Mean | Standard Deviation | ng-eq/mL | 24 hours:pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours 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 | 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose). BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tiredness | General disorders | MedDRA |
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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 |
|---|---|
| C549349 | opicapone |
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| Area Under the Plasma-concentration Time Curve Until the Last Quantifiable Sampling Point (AUC0-t) | Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites | 24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose |
| Area Under the Plasma-concentration Time Curve With Extrapolation to Infinity (AUC0-∞) | Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites | 24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Time to Reach Maximum Plasma Concentration (Tmax) | Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites | Posted | Mean | Standard Deviation | hours | 24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose |
|
|
|
| Secondary | Area Under the Plasma-concentration Time Curve Until the Last Quantifiable Sampling Point (AUC0-t) | Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites | Posted | Mean | Standard Deviation | h⋅ng-eq/mL | 24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose |
|
|
|
| Secondary | Area Under the Plasma-concentration Time Curve With Extrapolation to Infinity (AUC0-∞) | Whole blood samples for total radioactivity analysis, plasma samples for total radioactivity analysis, and plasma samples for analysis of BIA 9-1067 and its metabolites | Posted | Mean | Standard Deviation | h⋅ng-eq/mL | 24 hours at the following times: pre-dose and 1, 1.75, 2.25, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48, 72, 120, 168, 216, and 264 hours post-dose |
|
|
|
| 0 |
| 4 |
| 3 |
| 4 |
| Headache | Nervous system disorders |
|
| Flatulence | Gastrointestinal disorders |
|
| Loose stools | Gastrointestinal disorders |
|
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |