Lymphoma Clinical Trial
Official title:
Study of the Effect of Esomeprazole or Rifampin on the Pharmacokinetics of Alisertib and Evaluation of the Effect of Alisertib on the QTc Interval in Patients With Advanced Solid Tumors or Lymphomas
The purpose of this study is to assess the drug-drug interaction (DDI) of either esomeprazole or rifampin on the single-dose PK of alisertib, and to complete an intensive QT study of single and multiple-dose alisertib.
The drug tested in this study is called alisertib. Alisertib is being tested to assess the
effect of a proton pump inhibitor and strong metabolic inducer on the PK of a single 50 mg
dose of alisertib administered as enteric-coated tablets (ECTs).
The study enrolled 55 patients. Participants received either:
- Esomeprazole 40 mg and Alisertib 50 mg
- Rifampin 600 mg and Alisertib 50 mg
All participants were asked to take one tablet of alisertib either once or twice daily in all
cycles. In Cycle 2, participants were asked to take alisertib plus either esomeprazole or
rifampin.
This trial was conducted the United States. The overall time to participate in this study was
10 months. Participants made multiple visits to the clinic plus a final visit, 30 days after
receiving their last dose of study drug for a follow-up assessment.
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