NCT03174041

A Drug-Drug Interaction Study Between GDC-0853 and Midazolam, Itraconazole, Rosuvastatin, and Simvastatin

A 4-Part Phase 1 Study to Evaluate the Effect of GDC-0853 on the Pharmacokinetics of Midazolam, Rosuvastatin, and Simvastatin and the Effect of Itraconazole on the Pharmacokinetics of GDC-0853

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the potential for a drug interaction between GDC-0853 and midazolam, itraconazole, rosuvastatin, and simvastatin.

Detailed description

This will be a 4-part study, with each part being an open-label fixed-sequence evaluation conducted in healthy adult participants. Approximately 64 participants will be enrolled in this study.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	Midazolam	Single dose midazolam
DRUG	GDC-0853	Multiple doses GDC-0853 for 6 days
DRUG	Midazolam and GDC-0853	Multiple doses GDC-0853 and single dose midazolam
DRUG	Rosuvastatin	Single dose rosuvastatin
DRUG	Rosuvastatin and GDC-0853	Multiple doses GDC-0853 and single dose rosuvastatin
DRUG	Simvastatin	Single dose simvastatin
DRUG	Simvastatin and GDC-0853	Multiple doses GDC-0853 and single dose simvastatin
DRUG	GDC-0853	Single dose GDC-0853
DRUG	Itraconazole	Multiple doses itraconazole for 6 days
DRUG	GDC-0853 and itraconazole	Multiple doses itraconazole and single dose GDC-0853

Timeline

• Start date: 2017-04-18
• Primary completion: 2017-06-23
• Completion: 2017-06-23
• First posted: 2017-06-02
• Last updated: 2019-09-24

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study