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Evaluate the Effect of Entrectinib on the Pharmacokinetics of Midazolam in Cancer Patients

NCT03330990 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-08-21

No results posted yet for this study

Summary

This is an open-label study in advanced solid tumor patients to determine if entrectinib affects the pharmacokinetics of midazolam and any of its pharmacologically active metabolites.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

Entrectinib

600 mg oral capsule (fasted and fed)

DRUG

Midazolam Hydrochloride

2 mg oral syrup (fasted)

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-14
Primary Completion
2018-07-11
Completion
2018-07-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

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 NCT03330990 on ClinicalTrials.gov