NCT04226833View on ClinicalTrials.gov

A Study to Investigate the Effect of Impaired Hepatic Function on the Pharmacokinetics of Entrectinib in Volunteers With Different Levels of Hepatic Function

PHASE1CompletedINTERVENTIONAL

Enrollment

Participants

Timeline

Start Date

February 11, 2020

Primary Completion Date

September 27, 2021

Study Completion Date

September 27, 2021

Conditions

Hepatic Insufficiency

Interventions

DRUG

entrectinib

1x100 milligram (mg) capsule given with approximately 240 milliliter (mL) of water within 30 minutes of consumption of a standardized meal

Trial Locations (3)

3529

CRU Hungary Kft, Miskolc

170 00

Pharmaceutical Research Associates CZ, s.r.o., Prague

831 01

Summit Clinical Research s.r.o.; Oddelenie internej mediciny a klinickej farmakologie, Bratislava

All Listed Sponsors

lead

Hoffmann-La Roche

INDUSTRY

NCT04226833 - A Study to Investigate the Effect of Impaired Hepatic Function on the Pharmacokinetics of Entrectinib in Volunteers With Different Levels of Hepatic Function | Biotech Hunter | Biotech Hunter