NCT03290703

A Study to Investigate the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics (PK) of GDC-0853 in Healthy Participants

A Phase I, Single Center, Randomized, Open-Label Study Investigating the Effect of Formulation, Food, and Rabeprazole on the Pharmacokinetics of GDC-0853 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 63 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the PK of GDC-0853 following changes to formulation and in the presence or absence of food, the proton pump inhibitor (rabeprazole), or both. This will be a 3-part open-label randomized study conducted in healthy adult participants. Approximately 63 subjects will be enrolled in this study.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	GDC-0853	Participants will receive different formulations of GDC-0853 tablet.
DRUG	Rabeprazole	Participants will receive rabeprazole 20 mg twice daily (BID) for three days prior to GDC-0853 administration and a single dose coadministered with GDC-0853.

Timeline

• Start date: 2017-04-18
• Primary completion: 2018-10-25
• Completion: 2018-10-25
• First posted: 2017-09-25
• Last updated: 2019-09-11

Locations

1 site across 1 country: United Kingdom