CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 31 enrolled
Drug / intervention
Entrectinib 600 mg (T1) +3 moredrug
Likely dose
Entrectinib 600 mg (T1)from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03961100
NCT03961100Phase 1Completed
CompareCT.gov

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

Genentech, Inc.·interventional·Posted May 23, 2019·Updated Sep 7, 2020

In Brief

A Phase 1 clinical trial evaluating Entrectinib 600 mg (T1), Entrectinib 600 mg (T2), and 2 other interventions for Solid Tumor. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSolid Tumor
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedMay 23, 2019
Enrollment StartJun 6, 2019
Primary CompletionAug 9, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.1 years ago

Interventions

Entrectinib 600 mg (T1)drug

Test formulation 1 (T1): Multi-particulate formulation 1: entrectinib film-coated mini-tablets

Entrectinib 600 mg (T2)drug

Test formulation 2 (T2): Multi-particulate formulation 2: entrectinib film-coated mini-tablets

Entrectinib 200 mg (R)drug

Reference formulation (R): entrectinib hard capsules

Entrectinib 200 mg (T)drug

Test formulation (T): entrectinib HPMC capsules