Study Stopped
This study will be conducted in healthy volunteer subjects.
A Study to Assess the Effect of Rifampin on the Metabolism of ABT-199
A Phase 1 Study to Assess the Effect of Rifampin on the Pharmacokinetics of ABT-199
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2013
CompletedFirst Posted
Study publicly available on registry
October 25, 2013
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedMay 26, 2014
May 1, 2014
1 month
October 22, 2013
May 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
Number of subjects with adverse events
Measured up to 30 days after the last dose of study drug
Percentage of subjects with adverse events
Measured up to 30 days after the last dose of study drug
Change in physical exam finding, including vital signs
Measured from Day 1 up to 30 days after the last dose of study drug
Change in clinical laboratory test results
Measured from Day 1 up to 30 days after the last dose of study drug
Change in cardiac assessment findings
Measured from Day 1 up to Day 19
Study Arms (1)
Arm A (ABT-199 and rifampin)
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Subject must have relapsed or refractory non-Hodgkin's lymphoma.
You may not qualify if:
- 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:
- 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 any of the rifamycins.
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
- Genentech, Inc.collaborator
Study Sites (1)
Site Reference ID/Investigator# 101416
Hackensack, New Jersey, 07601, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David Chien, MD
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2013
First Posted
October 25, 2013
Study Start
April 1, 2014
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
May 26, 2014
Record last verified: 2014-05