Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects

Healthy Subjects Clinical Trial

Official title:

A Single-centre, Open, Single-dose, Self-control Study to Investigate the Effect of Itraconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04479891
• Other study ID #: HR-BLTN-DDI-01
• Status: Completed
• Phase: Phase 1
• Start date: September 18, 2019
• Est. completion date: November 30, 2019

Study information

• Verified date: July 2020
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 30, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• pyrotinib tablet
single oral dose of SHR6390 or co-administered with itraconazole
• Itraconazole capsule
200 mg itraconazole QD

Locations

Country	Name	City	State
China	The Second Hospital of Anhui Medical University	Hefei	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of pyrotinib	Maximum concentration (Cmax) of pyrotinib	Day 1 and Day 9
Primary	AUC of pyrotinib	Area under the plasma concentration versus time curve of SHR6390	Day 1 and Day 9
Secondary	Tmax of pyrotinib	Time of maximum concentration of pyrotinib	Day 1 and Day 9
Secondary	T1/2 of pyrotinib	Terminal half-life of pyrotinib	Day 1 and Day 9
Secondary	AEs and SAEs	Adverse events and serious adverse events	From the first drug administration to 7 days after the last drug administration