NCT03796260

A Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Participants

A Randomized, Open-Label, Two-Treatment, Two-Period, Two-Way Crossover Study to Investigate the Relative Bioavailability of Entrectinib Capsule Formulations F1 and F06 Under Fed Conditions in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study aims to investigate the relative bioavailability, safety, and tolerability of entrectinib capsule formulations F1 and F06 under fed conditions in healthy adult male and female participants.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Entrectinib Test Formulation (F1)	Participants will receive a single oral dose of entrectinib F1 after completion of a standardized meal.
DRUG	Entrectinib Reference Formulation (F06)	Participants will receive a single oral dose of entrectinib F06 after completion of a standardized meal.

Timeline

• Start date: 2019-01-09
• Primary completion: 2019-02-04
• Completion: 2019-02-04
• First posted: 2019-01-08
• Last updated: 2020-02-26
• Results posted: 2020-02-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study