Evaluation of the Relative Bioavailability and Food Effect of GDC-9545 in Healthy Females of Non-Childbearing Potential

ClinicalTrials.gov ID: NCT04274075

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Official title

A Phase 1, Open-Label, Single-Dose, Randomized, Three-Period Crossover Study to Evaluate the Relative Bioavailability and Food Effect of GDC-9545 in Healthy Female Subjects of Non-Childbearing Potential

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This study will be an open-label, randomized, three-period, six-sequence crossover study of GDC-9545 administered to healthy females of non-childbearing potential to determine the relative bioavailability of the Phase 3 capsule formulation to the Phase 1 tablet formulation in the fasted state and the effect of food on the Phase 3 capsule formulation.

Study identification

NCT ID: NCT04274075
Recruitment status: Completed
Study type: Interventional
Phase: Phase 1
Lead sponsor: Genentech, Inc.; Industry
Enrollment: 18 participants

Conditions and interventions

Conditions

Healthy Volunteers

Interventions

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: Female
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Mar 6, 2020 (Actual)
Primary completion: Apr 16, 2020 (Actual)
Completion: Apr 16, 2020 (Actual)
Last update posted: Apr 28, 2021

2020

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Covance Research Unit - Daytona	Daytona Beach	Florida	32117	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04274075, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Apr 28, 2021 · Synced Nov 13, 2026