NCT03961100

A Performance and Bioavailability Study of Entrectinib in Healthy Volunteers.

A Randomized, Open-Label, Two Part Study to Explore the Performance of Entrectinib Prototype Mini-Tablet Formulations and the Effect of Drug Substance Particle Size On Entrectinib Bioavailability in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate the bioavailability, palatability, safety and tolerability of entrectinib in healthy volunteers. Part 1 of the study will explore the performance of entrectinib multi-particle formulation. Part 2 will evaluate the effect of drug substance particle size on entrectinib bioavailability.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	Entrectinib 600 mg (T1)	Test formulation 1 (T1): Multi-particulate formulation 1: entrectinib film-coated mini-tablets
DRUG	Entrectinib 600 mg (T2)	Test formulation 2 (T2): Multi-particulate formulation 2: entrectinib film-coated mini-tablets
DRUG	Entrectinib 200 mg (R)	Reference formulation (R): entrectinib hard capsules
DRUG	Entrectinib 200 mg (T)	Test formulation (T): entrectinib HPMC capsules

Timeline

• Start date: 2019-06-06
• Primary completion: 2019-08-09
• Completion: 2019-08-09
• First posted: 2019-05-23
• Last updated: 2020-09-07
• Results posted: 2020-09-07

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study