Evaluation of CYP3A-Mediated Drug-Drug Interactions With Romidepsin in Patients With Advanced Cancer

被引:6
|
作者
Laille, Eric [1 ]
Patel, Manish [2 ,3 ]
Jones, Suzanne F. [3 ]
Burris, Howard A., III [3 ,4 ]
Infante, Jeffrey [3 ,4 ]
Lemech, Charlotte [5 ]
Liu, Liangang [1 ]
Arkenau, Hendrik-Tobias [5 ,6 ]
机构
[1] Celgene Corp, Summit, NJ USA
[2] Florida Canc Specialists, Sarasota, FL USA
[3] Sarah Cannon Res Inst, Nashville, TN USA
[4] Tennessee Oncol PLLC, Nashville, TN USA
[5] Sarah Cannon Res Inst UK, London, England
[6] UCL, London, England
来源
JOURNAL OF CLINICAL PHARMACOLOGY | 2015年 / 55卷 / 12期
关键词
romidepsin; ketoconazole; rifampin; drug-drug interaction; pharmacokinetics; HISTONE DEACETYLASE INHIBITOR; CHRONIC LYMPHOCYTIC-LEUKEMIA; P-GLYCOPROTEIN; DEPSIPEPTIDE FR901228; RIFAMPIN; PHARMACOKINETICS; FK228; ENZYMES; DIGOXIN; INDUCER;
D O I
10.1002/jcph.560
中图分类号
R9 [药学];
学科分类号
1007 ;
摘要
Two multicenter, single-arm, single-infusion, open-label studies were conducted to evaluate the effect of ketoconazole (a strong CYP3A inhibitor) or rifampin (a strong CYP3A inducer) daily for 5 days on the pharmacokinetics (PK) and safety of romidepsin (8 mg/m(2) intravenous 4-hour infusion for the ketoconazole study or a 14 mg/m(2) intravenous 4-hour infusion for the rifampin study) in patients with advanced cancer. Romidepsin coadministered with ketoconazole (400 mg) or rifampin (600 mg) was not bioequivalent to romidepsin alone. With ketoconazole, the mean romidepsin AUC and C-max were increased by approximately 25% and 10%, respectively. With rifampin, the mean romidepsin AUC and C-max were unexpectedly increased by approximately 80% and 60%, respectively; this is likely because of inhibition of active liver uptake. For both studies, romidepsin clearance and volume of distribution were decreased, terminal half-life was comparable, and median T-max was similar. Overall, the safety profile of romidepsin was not altered by coadministration with ketoconazole or rifampin, except that a higher incidence and greater severity of thrombocytopenia was observed when romidepsin was given with rifampin. The use of romidepsin with rifampin and strong CYP3A inducers should be avoided. Toxicity related to romidepsin exposure should be monitored when romidepsin is given with strong CYP3A inhibitors.
引用
收藏
页码:1378 / 1385
页数:8
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