Clinical Trial

Testing Experimental Medication in Healthy Subjects

Study Description

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

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Patients and healthy individuals accepted Patients and healthy individuals accepted

Drug - GDC-9545 Tablet: Treatment A

One dose of the GDC-9545 Phase 1 reference tablet formulation (three tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.

Drug - GDC-9545 Capsule: Treatment B

One dose of the GDC-9545 Phase 3 capsule formulation (one capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.

Drug - GDC-9545 Capsule: Treatment C

One dose of the GDC-9545 Phase 3 capsule formulation (one capsule) administered orally with approximately 240 mL room temperature water within 30 minutes of eating a high-fat meal.

Additional Information

Official Study 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

Clinical Trial ID

NCT04274075

ParticipAid ID

dL9Lpe