NCT02722018

Study to Investigate the Effect of Formulation and Food on the Pharmacokinetics of GDC-0810

A Phase I, Randomized, Open-Label, Single Center Study to Investigate the Effect of Formulation and Food on the Pharmacokinetics of GDC-0810 in Female Healthy Subjects on Non-Childbearing Potential

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: Female
• Age: 40 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, randomized, open-label, single center, crossover study to investigate the effect of formulation and food on the pharmacokinetics of GDC-0810 in female healthy participants of non-childbearing potential. This study is divided into three parts. Participants in each part will be randomized to one of three treatment sequences. Part 1 study in 4 periods will investigate the effect of formulation on the pharmacokinetics (PK) of GDC-0810 administered with low-fat food. Each participant in this part will receive a single dose of GDC-0810 dose level A following consumption of a low fat meal (30 minutes after the start of the meal) in each treatment period. Part 2 is an optional Phase I study in 3 periods to investigate the effect of formulation on the PK of GDC-0810 administered with low-fat food in healthy female participants of non-childbearing potential. Part 3 study in three periods will compare the PK of a Phase III prototype tablet formulation selected from Parts 1 and 2 of the study with the Phase II tablet formulation (both administered 30 minutes after the start of a low fat meal) at dose level B and to investigate the PK of the Phase III prototype formulation administered in the fasted state.

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	GDC-0810 Phase II Tablet	Participants will receive dose level A (in Parts 1 and 2) or dose level B (in Part 3) tablets.
DRUG	GDC-0810 Phase III Prototype Tablet	Participants will receive dose level A (in Parts 1 and 2) or dose level B (in Part 3) tablets.

Timeline

• Start date: 2016-01-06
• Primary completion: 2016-09-13
• Completion: 2016-09-13
• First posted: 2016-03-29
• Last updated: 2017-08-22

Locations

1 site across 1 country: United Kingdom