A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-199
NCT ID: NCT01969669
Last Updated: 2017-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2013-12-31
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Arm A (ABT-199 and ketoconazole)
ABT-199
Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with ketoconazole
Ketoconazole
Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with ketoconazole
Interventions
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ABT-199
Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with ketoconazole
Ketoconazole
Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with ketoconazole
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Subject must have adequate bone marrow (independent of growth factor support per local laboratory reference range), coagulation, renal and hepatic function:
* Absolute Neutrophil Count (ANC) greater than or equal to 1000/µL (without growth factor support unless neutropenia is clearly due to underlying disease);
* Platelets greater than or equal to 75,000/mm3 (unless thrombocytopenia is clearly due to disease-related immune thrombocytopenia or to underlying disease; entry platelet count must be independent of transfusion within 14 days of Screening);
* Hemoglobin greater than or equal to 9.0 g/dL (unless anemia is clearly due to underlying disease; entry hemoglobin must be independent of transfusion within 14 days of Screening);
* If cytopenias are present, no evidence of myelodysplastic syndrome or hypoplastic bone marrow;
* Subject must have activated partial thromboplastin time (aPTT) and prothrombin time (PT) not to exceed 1.5 × the upper normal limit (ULN);
* Calculated creatinine clearance greater than or equal to 50 mL/min using a 24-hour urine collection for creatinine clearance or per the Cockcroft-Gault equation;
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) less than or equal to 3.0 × ULN of institution's normal range;
* Bilirubin less than or equal to 1.5 × ULN. Subjects with Gilbert's Syndrome may have a bilirubin greater than 1.5 × ULN per discussion with the AbbVie medical monitor.
* Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease (PTLD), Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), or mantle cell lymphoma (MCL).
* Subject is receiving combination anti-retroviral therapy for HIV (due to potential drug-drug interactions between anti-retroviral medications and ABT-199, as well as anticipated ABT-199 mechanism based lymphopenia that may potentially increase the risk of opportunistic infections).
* Subject has hypersensitivity to ketoconazole.
* Subject has a cardiovascular disability status of New York Heart Association Class greater than or equal to 2. Class 2 is defined as cardiac disease in which patients are comfortable at rest but ordinary physical activity results in fatigue, palpitations, dyspnea or anginal pain.
* Subject has a significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease within the past 6 months that in the opinion of the investigator would adversely affect his/her participating in this study.
* Subject has malabsorption syndrome or other condition which precludes enteral route of administration (e.g., prior surgical resection).
* Subject has undergone an allogeneic stem cell transplant.
18 Years
99 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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David Chien, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
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Site Reference ID/Investigator# 97498
Tucson, Arizona, United States
Site Reference ID/Investigator# 92593
Lebanon, New Hampshire, United States
Site Reference ID/Investigator# 101415
Hackensack, New Jersey, United States
Countries
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References
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Agarwal SK, Salem AH, Danilov AV, Hu B, Puvvada S, Gutierrez M, Chien D, Lewis LD, Wong SL. Effect of ketoconazole, a strong CYP3A inhibitor, on the pharmacokinetics of venetoclax, a BCL-2 inhibitor, in patients with non-Hodgkin lymphoma. Br J Clin Pharmacol. 2017 Apr;83(4):846-854. doi: 10.1111/bcp.13175. Epub 2017 Jan 18.
Other Identifiers
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M13-364
Identifier Type: -
Identifier Source: org_study_id