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This study will now be conducted in healthy volunteers.
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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A pharmacokinetic study to access how the body absorbs and removes ABT-199 in adults with Non-Hodgkin's Lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]ABT-199 | Experimental | Subjects with relapsed or refractory Non-Hodgkin's Lymphoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]ABT-199 (GDC-0199) | Drug | [14C]ABT-199 will be administered as a single oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of ABT-199 and [14C]ABT-199 | For approximately 9 days following a single oral dose of [14C]ABT-199 | |
| Time to Cmax (Tmax) for ABT-199 and [14C]ABT-199 | For approximately 9 days following a single oral dose of [14C]ABT-199 | |
| Area Under the Time curve (AUC) for ABT-199 and [14C]ABT-199 | The area under the exposure-time curve from time zero to Day 9 and time zero extrapolated to infinite time for single dose of [14C]ABT-199 | For approximately 9 days following a single oral dose of [14C]ABT-199 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | Adverse event monitoring, lab test assessment, physical exam and vital signs will be evaluated throughout the study. | At each visit (daily for approximately the first 9 days) |
| Percentage of subjects with adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justin L Ricker, MD | AbbVie | Study Director |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
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Adverse event monitoring, lab test assessment, physical exam and vital signs will be evaluated throughout the study. |
| At each visit (daily for approximately the first 9 days) |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |