NCT01249118

An Absolute Bioavailability Study in Healthy Participants Comparing Oral to Intravenous Administration of GDC-0973 (Cobimetinib)

A Phase 1, Single Dose, Randomized, Cross-over Absolute Bioavailability Study in Healthy Subjects Comparing Oral to Intravenous Administration of GDC-0973

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The primary objective of Part 1 of this study is to evaluate the safety and tolerability of the intravenous (IV) dose of GDC-0973. The primary objectives of Part 2 of this study are to evaluate the absolute bioavailability of GDC-0973 and to evaluate the pharmacokinetic (PK) of GDC-0973 following IV and oral administration. The secondary objective of Part 2 of this study is to evaluate the safety of GDC-0973 administered orally and intravenously.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	GDC-0973 IV Infusion	IV infusion.
DRUG	GDC-0973 Oral Capsules	Oral dose.

Timeline

• Start date: 2010-11-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2010-11-29
• Last updated: 2017-05-10
• Results posted: 2017-02-06