This is an open-label multicenter, study to assess the pharmacokinetic interaction of ketoconazole 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 ketoconazole and to assess the safety of ABT-199 in combination with ketoconazole. Subjects may enroll in a separate extension study to continue receiving ABT-199 after completion of this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
12
Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with ketoconazole
Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with ketoconazole
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
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 ketoconazole
Time frame: Measured pre-dose and up to 96 hours post-dose ABT-199
Number of subjects with adverse events
Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study
Time frame: Measured up to 30 days after the last dose of study drug
Percentage of subjects with adverse events
Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study
Time frame: 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
Time frame: 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
Time frame: Measured from Day 1 up to 30 days after the last dose of study drug
Change in cardiac assessment findings
Electrocardiogram
Time frame: Measured from Day 1 up to Day 12
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