A Randomized, Open, Single-dose, Two-cycle, Double-sequence, Crossover Study to Investigate the Effects of a Low-fat Diet On the Pharmacokinetics of Healthy Chinese Adult Participants After Oral Administration of Pyrotinib Maleate Tablets

Jiangsu HengRui Medicine Co., Ltd.0 sites16 target enrollmentMarch 2020

ConditionsHealthy Participants

Interventionspyrotinib maleate fasted in P1, low-fat diet in P2 pyrotinib maleate low-fat diet in P1, fasted in P2

Drugspyrotinib maleate fasted in P1, low-fat diet in P2 pyrotinib maleate low-fat diet in P1, fasted in P2

Overview

Phase: Phase 1
Intervention: pyrotinib maleate fasted in P1, low-fat diet in P2
Conditions: Healthy Participants
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 16
Primary Endpoint: Pharmacokinetics parameter: Cmax of pyrotinib
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The primary objective of the study is to evaluate the effect of low-fat diet on pharmacokinetics of healthy Chinese adult participants after oral administration of pyrotinib maleate tablets.

The secondary objective of the study is to evaluate the safety of single dose of pyrotinib orally in healthy participants.

Registry

clinicaltrials.gov

Start Date

March 2020

End Date

April 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Sign the informed consent before the trial, and fully understand the trial content, process and possible adverse reactions;
•Ability to complete the study as required by the protocol;
•Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;
•Have no fertility plan and agree to adopt effective contraceptive measures within 2 weeks before the first study drug administration and up to 3 months after the last study drug administration. Negative pregnancy test for women of child-bearing age before the first study drug administration;
•Male body weight ≥ 50kg, female body weight ≥ 45kg, and body mass index (BMI) within the range of 19 \~ 26 kg/m\^2 (including 19 and 26);
•During screening period, the comprehensive physical examination (vital signs and physical examination), routine laboratory examination (blood routine, urine routine, blood biochemistry, coagulation,etc), 12-lead electrocardiogram (ECG), chest X-ray, cardiac ultrasound, B ultrasound and other examination results must be within the normal range, or judged to be "no clinical significance (NCS)" if beyond the normal range;

Exclusion Criteria

•Blood donation within 3 months before the first drug administration and blood loss greater than 400 mL, or receiving blood transfusion;
•Allergic constitution, including those with severe drug allergies or a history of drug allergies, or known allergy to the research drug;
•History of drug use, or drug abuse screening positive; history of drug abuse within the past five years or have used drugs 3 months before the test;
•Alcoholic or often drinkers (the average drinking amount is more than 14 units a week: 1 unit= 285 ml beer or 45 ml spirits or 100 ml wine; ≥5 cigarettes per day) and can't quit smoking and alcohol during the study; alcohol test positive;
•The 12-lead ECG with female QTcF \> 470ms or male QTcF \> 450ms;
•Left ventricular ejection fraction (LVEF) \<50% by echocardiography;
•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.
•Those who have undergone any surgery within 6 months before screening;
•Those who have taken hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for a long time within the 6 months before screening;
•Those who have taken any research drugs within 3 months before the first drug administration;

Arms & Interventions

A

Intervention: pyrotinib maleate fasted in P1, low-fat diet in P2

B

Intervention: pyrotinib maleate low-fat diet in P1, fasted in P2

Outcomes

Primary Outcomes

Pharmacokinetics parameter: Cmax of pyrotinib

Time Frame: through study completion, an average of 28 days

Peak Plasma Concentration (Cmax) of pyrotinib

Pharmacokinetics parameter: AUC of pyrotinib

Time Frame: through study completion, an average of 28 days

Area under the plasma concentration versus time curve (AUC) of pyrotinib

Secondary Outcomes

Pharmacokinetics parameter: CL/F of pyrotinib(through study completion, an average of 28 days)
Pharmacokinetics parameter: Vz/F of pyrotinib(through study completion, an average of 28 days)
Pharmacokinetics parameter: T1/2 of pyrotinib(through study completion, an average of 28 days)
Pharmacokinetics parameter: Tmax of pyrotinib(through study completion, an average of 28 days)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(through study completion, an average of 28 days)