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A Study To Test The Effect Of Apatinib On P450 Enzymes

NCT03245307 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-02-07

No results posted yet for this study

Summary

Apatinib, an oral inhibitor of vascular endothelial growth factor receptor 2（VEGFR-2）, inhibits multiple cytochrome P450 (CYP450) enzymes in vitro. This study in patients with advanced cancer evaluated the effect of Apatinib on CYP450 function by comparing the pharmacokinetics of CYP-specific probe drugs in the presence and absence of Apatinib. The probes used included Nifedipine (CYP3A specific), warfarin (CYP2C9 specific).

Conditions

  • Cytochrome P450 Interaction

Interventions

DRUG

Apatinib

Apatinib at a dosage of 750mg will be administered daily from day 9 of phase A

DRUG

Nifedipine GTIS

Nifedipine at a dosage of 30mg will be administered at day 1 and day 14 of phase A

DRUG

Warfarin Potassium

Nifedipine at a dosage of 3mg will be administered at day 3 and day 16 of phase A

Sponsors & Collaborators

  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-22
Primary Completion
2018-04-30
Completion
2018-09-30

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 NCT03245307 on ClinicalTrials.gov