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A Performance and Bioavailability Study of Entrectinib in Healthy Volunteers.

NCT03961100 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2020-09-07

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Genentech, Inc.

    lead INDUSTRY

Principal Investigators

  • Clinical trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-06-06
Primary Completion
2019-08-09
Completion
2019-08-09
FDA Drug
Yes

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03961100 on ClinicalTrials.gov