A Pharmacokinetic Study to Access How the Body Absorbs and Removes ABT-199 in Adults With Non-Hodgkin's Lymphoma

Study Overview
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Brief Summary
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A pharmacokinetic study to access how the body absorbs and removes ABT-199 in adults with Non-Hodgkin's Lymphoma.

Official Title
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Disposition of [14C] ABT-199 in Subjects With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL) Following a Single Oral Dose Administration

Conditions
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Relapsed/Refractory Non-Hodgkin's Lymphoma

Intervention / Treatment
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* Drug: [14C]ABT-199 (GDC-0199)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have relapsed or refractory disease. Subject must have histologically documented diagnosis of non-hodgkin's lymphoma as defined by a B-cell neo-plasm in the World Health Organization (WHO) classification scheme except as noted in exclusion criteria. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0-2. Subject has adequate bone marrow (independent of growth factor support per local laboratory reference range). Subject has adequate coagulation, renal and hepatic function. Exclusion Criteria: Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), mantle cell leukemia (MCL), or small lymphocytic lymphoma (SLL). Subject has undergone an allogeneic stem cell transplant. Subject is receiving combination anti-retroviral therapy for human immunodeficiency virus (HIV) (due to potential drug-drug interactions, as well as the potential for increased risk of opportunistic infections). Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease within 6 months that in the opinion of the Investigator would adversely affect his/her participation in this study. Subject has active peptic ulcer disease or other hemorrhagic esophagitis/gastritis.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [14C]ABT-199<br>Subjects with relapsed or refractory Non-Hodgkin's Lymphoma | Drug: [14C]ABT-199 (GDC-0199)<br>* [14C]ABT-199 will be administered as a single oral administration<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GDC-0199, ADME, Relapsed, Refractory, ABT-199, Non-Hodgkin's Lymphoma