Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects

NCT ID: NCT04479891

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-18
• Study Completion Date: 2019-11-30

Brief Summary

The study will assess the effect of multiple oral doses of itraconazole on the single dose pharmacokinetic parameters of pyrotinib in healthy Chinese subjects. The safety of pyrotinib alone and when co-administered with itraconazole will also be assessed.

Conditions

Healthy Subjects

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

pyrotinib alone, pyrotinib + itraconazole

Sequential treatments of pyrotinib alone followed by pyrotinib + itraconazole, with a washout period in between.

Group Type: EXPERIMENTAL

pyrotinib tablet

Intervention Type: DRUG

single oral dose of SHR6390 or co-administered with itraconazole

Itraconazole capsule

Intervention Type: DRUG

200 mg itraconazole QD

Interventions

pyrotinib tablet

single oral dose of SHR6390 or co-administered with itraconazole

Intervention Type: DRUG

Itraconazole capsule

200 mg itraconazole QD

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
• Able to complete the study as required by the protocol;
• Subjects have no birth plan and voluntarily take effective contraception from 2 weeks before administration to 3 months after the last dose, and the pre-drug serum HCG test for fertility-enabled women must be negative;
• Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 26 kg/m2 ;
• No clinically significant abnormalities in general physical examination, vital signs, laboratory tests, etc.

Exclusion Criteria

• Blood donation no less than 400 mL or have blood transfusion within 3 months of dosing.
• Allergic constitution or known allergy to pyrotinib, itraconazole or the excipients;
• History of drug abuse in the past 5 years, or positive for drug abuse screening;
• Alcoholic or often drinkers with drinking amount more than 14 units a week; a heavy smoker; and can't abstain from smoking and alcohol during the study
• Left ventricular ejection fraction (LVEF) <50% by echocardiography or QTcF ≥ 470 msec by 12 lead electrocardiograph;
• A clear medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system that are not suitable for subjects to participate in the study, as judged by the investigator;
• Any surgery within 6 months before screening;
• Have taken hepatotoxic drugs for a long time within 6 months before screening;
• Subjects who took any clinical trial drugs within 3 months;
• Subjects who took any drugs that change liver enzymes activity within 28 days before dosing; or took any prescription drugs, over-the-counter drugs or vitamins, health products or herbal medicine within 14 days before dosing;
• Hepatitis B surface antigen positive, hepatitis C antibody positive, syphilis antibody positive, HIV antibody positive;
• Subjects who took any beverage or food containing grapefruit, xanthine, caffeine, or alcohol within 48 hours before dosing; strenuous exercise; or other factors which affect drug absorption, distribution, metabolism, excretion, etc.;
• Other factors that are not suitable for subjects to participate in the study, as judged by the investigator.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Countries

China

Other Identifiers

HR-BLTN-DDI-01

Identifier Type: -

Identifier Source: org_study_id