NCT01814709

A Drug Interaction Study of GDC-0032 Co-administered With Rifampin or Itraconazole in Healthy Volunteers

A Phase 1, Open-Label Study to Evaluate the Effect of Rifampin or Itraconazole on the Pharmacokinetics of GDC-0032 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This open-label, two-arm, drug interaction study will investigate the effect of co-administration of rifampin or itraconazole on the pharmacokinetics of GDC-0032 in healthy volunteers. In Arm A, volunteers will receive GDC-0032 and rifampin; in Arm B, volunteers will receive GDC-0032 and itraconazole. The anticipated time on study treatment is approximately 30 days.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	GDC-0032	Oral doses of GDC-0032
DRUG	Itraconazole	Oral doses of Itraconazole
DRUG	Rifampin	Oral doses of Rifampin

Timeline

• Start date: 2013-04-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2013-03-20
• Last updated: 2016-11-02

Locations

1 site across 1 country: United States