NCT04680273

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

A Phase I, Single Center, Open-Label, Partially Randomized, Two Part Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-9545 Following a Single Oral Dose (Part 1) and to Evaluate the Absolute Bioavailability of Oral Capsule Formulations of GDC-9545 F12 and F18 and the Relative Bioavailability of F18 Compared to F12 (Part 2) in Healthy Female Subjects of Non-Childbearing Potential

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: Female
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is an open-label, single-center, two part study in healthy female subjects of non-childbearing potential to investigate the absorption, metabolism, and excretion of \[14C\]-GDC-9545 (Part 1), the absolute bioavailability of formulations F12 and F18 (i.e., GDC-9545/F12 capsule, 30 mg and GDC-9545/F18 capsule, 30 mg) and relative bioavailability of GDC-9545 oral capsule F18 to the F12 formulation (Part 2). It is planned that Part 1 will begin prior to Part 2 of the study, and that the two parts of the study will partially overlap.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-07
• Primary completion: 2021-04-12
• Completion: 2021-04-12
• First posted: 2020-12-22
• Last updated: 2023-02-02
• Results posted: 2023-02-02

Locations

1 site across 1 country: United Kingdom