A study to find out what happens to a new medicine inside women’s bodies – and to look at different forms of the medicine (giredestrant)

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

  • Healthy Volunteers

Basic Details

Gender
Female
Age
≥30 Years & ≤ 65 Years
Healthy Volunteers
Accepts Healthy Volunteers
Sponsor Genentech, Inc.
Phase Phase 1
Study Identifier NCT04680273, GP42662, 2020-004650-29

This clinical trial was done to study a new medicine called, “giredestrant”, for the treatment of patients with ER+ breast cancer. This study was done to take a detailed look at what happens to giredestrant in the body of healthy women who were not pregnant, unable to have children, and were not breastfeeding. Sixteen healthy women took part in this study at one study center in one country – The United Kingdom.

The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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What is Clinical Research?

In clinical research, volunteers, researchers, and medical professionals work together toward a shared goal: better treatment outcomes for patients. Clinical trials are vital to their process. They are carefully designed and follow approved protocols.