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

NCT06492525 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-07-09

No results posted yet for this study

Summary

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

Conditions

  • Healthy

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

Sponsors & Collaborators

  • Betta Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2024-07-31
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • China

Study Locations

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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 NCT06492525 on ClinicalTrials.gov