NCT01772290

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

A Clinical Drug-Drug Interaction Study to Evaluate the Effect of a Proton Pump Inhibitor, a Combined P-gp/CYP3A4 Inhibitor, and a CYP2C9 Inhibitor on the Pharmacokinetics of Vismodegib

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	fluconazole	Multiple oral doses
DRUG	itraconazole	Multiple oral doses
DRUG	rabeprazole	Multiple oral doses
DRUG	vismodegib	Multiple oral doses

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-05-01
• Completion: 2013-05-01
• First posted: 2013-01-21
• Last updated: 2016-11-02

Locations

2 sites across 1 country: United States