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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-003163-39 | EudraCT Number |
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This is a single site, open label, single dose, non-randomized study in healthy male and female subjects. The subjects will be evaluated for plasma, urine and feces levels of 14C-ABR-215050 during 21 days.
As a part of the pharmacokinetic documentation, the metabolism and mass balance of 14C-ABR-215050 will be studied in healthy subjects. Female healthy subjects are included in the study in case of expanding the indication to female forms of cancer. In this study a single dose of 1.0 mg of the study drug will be administered orally as a solution under fasted conditions. The absorption and safety profiles for the oral water solution will also be documented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABR-215050 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABR-215050 | Drug | 1 mg ABR-215050 |
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| Measure | Description | Time Frame |
|---|---|---|
| To establish the metabolic pattern of ABR 215050 | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| To study the mass balance and to determine the disposition and pathways of elimination of 14C-ABR-215050. | 4 months | |
| To follow the safety profile | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marianne Ellman, BSc | Active Biotech Research AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| JJ Berzelius Clinical Research Center AB, Berzelius Science Park | Linköping | 582 25 | Sweden |
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| ID | Term |
|---|---|
| C516109 | tasquinimod |
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