A Study to Assess the Effect of Rifampin on the Metabolism of Navitoclax
This study has been completed.
Information provided by:
First received: May 10, 2010
Last updated: June 4, 2011
Last verified: May 2011
This is an open-label, single or multiple center study to determine the interaction of rifampin with navitoclax (ABT-263) in approximately 12 subjects with cancer.
Lymphoma, Including Chronic Lymphocytic Leukemia
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study to Assess the Effect of a CYP3A Inducer (Rifampin) on the Pharmacokinetics of ABT-263 (Navitoclax)|
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources: Chronic Lymphocytic Leukemia Leukemia, B-cell, ChronicU.S. FDA Resources
Further study details as provided by Abbott:
Primary Outcome Measures:
- To determine the effect of rifampin on the pharmacokinetics of navitoclax. [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- To determine the safety of navitoclax when administered alone and in combination with rifampin in these patients. [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2010|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
|Experimental: Arm A (navitoclax and rifampin)||
Subjects will be dosed with Navitoclax, then dosed with Navitoclax in combination with Rifampin.
Other Name: ABT-263, navitoclaxDrug: Rifampin
Subjects will be dosed with Navitoclax, then, dosed with Navitoclax in combination with Rifampin.
Other Name: rifampin
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