Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-9545 Following a Single Oral Dose (Part 1) and to Evaluate the Absolute and Relative Bioavailability of Oral Capsule Formulations of GDC-9545 (Part 2) in Healthy Female Subjects of Non-Childbearing Potential

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

January 7, 2021

Primary Completion Date

April 12, 2021

Study Completion Date

April 12, 2021

Conditions
Healthy Volunteers
Interventions
DRUG

[14C]-GDC-9545

Participants will receive a single oral dose of \[14C\]-GDC-9545 capsule, 30 milligrams (mg) (not more than \[NMT\] 4.6 megabecquerel \[MBq\]; 124 microcurie \[μCi\]) with approximately 240 millilitres (mL) water in the fasted state.

DRUG

GDC-9545 Solution for Infusion

Treatment B: 30 mg GDC-9545 as a solution for infusion, 3 mg/mL administered intravenously (IV) in 10 mL as an infusion over 30 minutes.

DRUG

GDC-9545/F12 Capsule

Treatment C: GDC-9545/F12 capsule, 30 mg, administered orally with approximately 240 mL water.

DRUG

GDC-9545/F18 Capsule

Treatment D: GDC-9545/F18 capsule, 30 mg, administered orally with approximately 240 mL water.

Trial Locations (1)

NG11 6JS

Quotient Sciences, Nottingham

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY