Effect of Fluconazole on the Pharmacokinetics of Pyrotinib in Healthy Subjects

NCT ID: NCT04850651

Last Updated: 2021-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-16
• Study Completion Date: 2021-05-17

Brief Summary

The primary objective of the study is to evaluate the effect of fluconazole on pharmacokinetics of pyrotinib tablet for oral administration in healthy Chinese adult subjects. The secondary objective of the study is to compare the safety of pyrotinib alone and co-administered with fluconazole.

Conditions

Healthy Subjects

Study Design

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

Study Groups

Pyrotinib/Fluconazole

Durg: Pyrotinib Durg: Pyrotinib/Fluconazole Participants received a single oral dose of pyrotinib 80 milligram (mg) on day1 and day9. Participants received a loading dose of fluconazole 400 mg on day6 followed by single dose of fluconazole 200 mg for oral administration from D7 to D18.

Group Type: EXPERIMENTAL

Pyrotinib；Fluconazole

Intervention Type: DRUG

Drug: Pyrotinib Participants received a single oral dose of Pyrotinib tablet on the morning of day1 in treatment period 1.

Drug: Pyrotinib/Fluconazole In treatment period 2, Participants received a single oral dose of pyrotinib tablet on the morning of day9, and received a loading dose of fluconazole capsule on day6 followed by single dose of fluconazole for oral administration from D7 to D18.

Interventions

Pyrotinib；Fluconazole

Drug: Pyrotinib Participants received a single oral dose of Pyrotinib tablet on the morning of day1 in treatment period 1.

Drug: Pyrotinib/Fluconazole In treatment period 2, Participants received a single oral dose of pyrotinib tablet on the morning of day9, and received a loading dose of fluconazole capsule on day6 followed by single dose of fluconazole for oral administration from D7 to D18.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Participants has given written informed consent with full understanding of the trial content, process and possible adverse reactions;

2. Ability to complete the study as required by the protocol;

3. Healthy male or female subjects aged 18 to 45 (including 18 and 45) at the date of signing the informed consent;

4. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, and body mass index (BMI) within the range of 19 ~ 26 kg /m2 (including 19 and 26);

5. Willing to take contraception or male subjects who can guarantee not to donate sperm during the trial and within 6 months after the last dose; female subjects with fertility who did not use contraception for at least 2 weeks before dosing;

Exclusion Criteria

1. Allergic constitution or Allergic to a drug ingredient or component;

2. History of drug use, or drug abuse screening positive;

3. Alcoholic or often drinkers;

4. Left ventricular ejection fraction (LVEF) <50% by echocardiography;

5. 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;

6. Abnormal clinical laboratory tests and clinical significance judged by the investigator or other clinical findings showing the following diseases, including but not limited to gastrointestinal tract, kidney, liver, nerve, blood, endocrine, tumor, lung, immune, mental or cardiovascular and cerebrovascular diseases;

7. Participated in a clinical trial and has received an investigational product within 3 months prior to the first dosing day in the current study;

8. Positive value of HBsAg、HCV-Ab、HIV-Ab、TPPA at screening；

9. Blood loss ≥400mL within 3 months before first dosing;

10. Patients who had a positive blood pregnancy test and were breastfeeding at the time of screening.

11. The investigators determined that other conditions were inappropriate for participation in this clinical trial .

• 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

Jinan Central Hospital

Jinan, Shandong, China

Countries

China

Other Identifiers

HR-BLTN-DDI-06

Identifier Type: -

Identifier Source: org_study_id