NCT01844583

Safety, Tolerability and Pharmacokinetic (PK) of Concomitant Esomeprazole and Rifampin, and QT Study on Single and Multiple-doses of Alisertib

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Solid Tumors
• Lymphoma

Interventions

Type	Name	Description
DRUG	Alisertib	Alisertib tablets
DRUG	Esomeprazole	Esomeprazole capsules
DRUG	Rifampin	Rifampin capsules

Timeline

• Start date: 2013-06-25
• Primary completion: 2014-08-04
• Completion: 2016-09-06
• First posted: 2013-05-01
• Last updated: 2019-03-25
• Results posted: 2019-03-25

Locations

7 sites across 1 country: United States