NCT04274075

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	GDC-9545 Tablet, Fasted: Treatment A	One dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.
DRUG	GDC-9545 Capsule, Fasted: Treatment B	One dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.
DRUG	GDC-9545 Capsule, Fed: Treatment C	One dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water within 30 minutes of eating a high-fat meal.

Timeline

• Start date: 2020-03-06
• Primary completion: 2020-04-16
• Completion: 2020-04-16
• First posted: 2020-02-18
• Last updated: 2021-04-28
• Results posted: 2021-04-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study