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This study will be conducted in healthy volunteer subjects.
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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This is an open-label multicenter, study to assess the pharmacokinetic interaction of rifampin with ABT-199 in up to 12 subjects with relapsed or refractory non-Hodgkin's lymphoma.
This is a Phase 1 study designed to assess how the body processes the study drug ABT-199 when taken alone and in combination with rifampin and to assess the safety of ABT-199 in combination with rifampin. Subjects may enroll in a separate extension study to continue receiving ABT-199 after completion of this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (ABT-199 and rifampin) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-199 | Drug | Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with rifampin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of maximum observed plasma concentration (Cmax), time to Cmax (peak time, Tmax), terminal phase elimination rate constant (beta), terminal phase elimination half-life (t1/2), & area under the plasma concentration-time curve (AUC) of ABT-199 | Blood samples for pharmacokinetic (PK) analysis of ABT-199 will be collected at designated timepoints to assess the PK parameters for ABT-199 alone relative to ABT-199 with rifampin | Measured pre-dose and up to 96 hours post-dose ABT-199 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study | Measured up to 30 days after the last dose of study drug |
| Percentage of subjects with adverse events |
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Inclusion Criteria:
Subject must have relapsed or refractory non-Hodgkin's lymphoma.
Subject must have histologically documented diagnosis of non-Hodgkin's lymphoma as defined by a B-cell neoplasm in the World Health Organization (WHO) classification scheme except as noted in the exclusion criteria.
Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2.
Subject must have adequate bone marrow (independent of growth factor support per local laboratory reference range), coagulation, renal and hepatic function:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Chien, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 101416 | Hackensack | New Jersey | 07601 | United States |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D012008 | Recurrence |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| ID | Term |
|---|---|
| C579720 | venetoclax |
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Rifampin | Drug | Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with rifampin |
|
Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study
| Measured up to 30 days after the last dose of study drug |
| Change in physical exam finding, including vital signs | Body temperature, weight, blood pressure, heart rate | Measured from Day 1 up to 30 days after the last dose of study drug |
| Change in clinical laboratory test results | Chemistry, coagulation, hematology, urinalysis | Measured from Day 1 up to 30 days after the last dose of study drug |
| Change in cardiac assessment findings | Electrocardiogram | Measured from Day 1 up to Day 19 |
| D006425 |
| Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |