NCT03807739

A Study to Determine the Bioavailability of Various Formulations of GDC-0134 in Healthy Female Participants of Non-Childbearing Potential

A Phase I Study to Determine the Relative Bioavailability of Various Formulations of GDC-0134 in Healthy Female Subjects of Non-Childbearing Potential

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a two-part study to determine the relative bioavailability of two different prototype capsules of GDC-0134 to that of an existing reference capsule of GDC-0134 under both fed and fasted conditions. The study is open to healthy female participants of non-childbearing potential.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	GDC-0134 F09 Formulation	Participants will receive a single oral dose of GDC-0134 reference capsule F09.
DRUG	GDC-0134 F15 Formulation	Participants will receive a single oral dose of GDC-0134 prototype capsule F15.
DRUG	GDC-0134 F16 Formulation	Participants will receive a single oral dose of GDC-0134 prototype capsule F16.

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-05-30
• Completion: 2019-05-30
• First posted: 2019-01-17
• Last updated: 2020-08-31
• Results posted: 2020-08-31

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study