At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating [14C]-GDC-9545, GDC-9545 Solution for Infusion, and 2 other interventions for Healthy Volunteers. Completed, enrolled 16 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.
Treatment C: GDC-9545/F12 capsule, 30 mg, administered orally with approximately 240 mL water.
Treatment D: GDC-9545/F18 capsule, 30 mg, administered orally with approximately 240 mL water.