A Drug-Drug Interaction Study of the Effect of Rabeprazole, Itraconazole or Fluconazole on the Pharmacokinetics of Vismodegib

Phase 1 Completed 92 enrolled Genentech, Inc.

RandomizedParallel-groupOpen-label

Summary

This randomized, open-label, 4-arm, multiple-dose study will evaluate the effect of coadministration of a protein pump inhibitor, an inhibitor of P-glycoprotein and CYP3A4, or an inhibitor of CYP2C9 on the pharmacokinetics of vismodegib in healthy female subjects of non-childbearing potential. Subjects will be randomized to receive multiple oral doses of vismodegib, alone or in combination with multiple oral doses of either rabeprazole, itraconazole or fluconazole. Anticipated time on study treatment is up to 11 days.

Timeline

Start: 2013-02
Primary completion: 2013-05
Completion: 2013-05

Publications

Malhi V, Colburn D, Williams SJ, Hop CE, Dresser MJ, Chandra P, Graham RA. A clinical drug-drug interaction study to evaluate the effect of a proton-pump inhibitor, a combined P-glycoprotein/cytochrome 450 enzyme (CYP)3A4 inhibitor, and a CYP2C9 inhibitor on the pharmacokinetics of vismodegib. Cancer Chemother Pharmacol. 2016 Jul;78(1):41-9. doi: 10.1007/s00280-016-3020-z. Epub 2016 May 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fluconazole	Small molecule	400 mg	Oral
Subject	Itraconazole	Small molecule	200 mg	Oral
Subject	Rabeprazole	Small molecule	20 mg	Oral
Subject	Vismodegib	Small molecule	150 mg	Oral

Indications

No indication recorded.