Evaluation of the Relative Bioavailability and Food Effect of GDC-9545 in Healthy Females of Non-Childbearing Potential

PHASE1CompletedINTERVENTIONAL
Enrollment

18

Participants

Timeline

Start Date

March 6, 2020

Primary Completion Date

April 16, 2020

Study Completion Date

April 16, 2020

Conditions
Healthy Volunteers
Interventions
DRUG

GDC-9545 Tablet, Fasted: Treatment A

One dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.

DRUG

GDC-9545 Capsule, Fasted: Treatment B

One dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.

DRUG

GDC-9545 Capsule, Fed: Treatment C

One dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water within 30 minutes of eating a high-fat meal.

Trial Locations (1)

32117

Covance Research Unit - Daytona, Daytona Beach

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY