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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

NCT04680273 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2023-02-02

Study results available
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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

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.

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Genentech, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-07
Primary Completion
2021-04-12
Completion
2021-04-12

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04680273 on ClinicalTrials.gov