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NOT YET RECRUITING
NCT06492525
PHASE1

A Study To Evaluate The Effect Of Rifampicin Or Ltraconazole On Pharmacokinetics Of Ensartinib In Healthy Volunteers

Sponsor: Betta Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

Summary

The purpose of this study is to estimate the effect of rifampicin or itraconazole on the single dose PK of ensartinib.

Official title: A Phase 1, Open-label, 2-period, Fixed Sequence, Cross-over Study To Investigate The Effect Of Multiple Doses Of Rifampicin Or Itraconazole On The Pharmacokinetics Of Single Dose Ensartinib In Healthy Volunteers.

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-07

Completion Date

2024-12

Last Updated

2024-07-09

Healthy Volunteers

Yes

Conditions

Interventions

DRUG

Ensartinib

225 mg oral dose on day 1 in period 1 and on day 18 in period 2

DRUG

Rifampicin

600 mg QD from day 9 to day 22 in period 2

DRUG

Itraconazole

200 mg QD from day 9 to day 19 in period 2

DRUG

Ensartinib

100 mg oral dose on day 1 in period 1 and on day 12 in period 2

Locations (1)

The Second Affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China