NCT01929876

A Study to Evaluate Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Participants

A Phase 1, Open-Label Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of Cobimetinib in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This open-label, 2-period, fixed sequence, drug interaction study will investigate the effect of co-administration of itraconazole on the pharmacokinetics of cobimetinib in healthy participants. Participants will receive multiple repeating doses of cobimetinib and itraconazole.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Cobimetinib	10 milligram (mg) (2\* 5 mg capsules) will be administered orally on Day 1 of Period 1 and Day 4 of Period 2
DRUG	Itraconazole	200 mg oral solution will be administered once daily from Day 1 to Day 14 of Period 2

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2013-08-28
• Last updated: 2016-08-04
• Results posted: 2016-08-04

Locations

1 site across 1 country: United States