Effect of Clarithromycin and Rifampicin on the Pharmacokinetics of XZP-3287 in Healthy Subjects

NCT ID: NCT04951713

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2021-12-31

Brief Summary

This is a phase I study to assess the drug-drug interaction of XZP-3287 and Clarithromycin/Rifampicin. The study also evaluates the pharmacokinetic and tolerability of XZP-3287 in healthy subjects.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

XZP-3287 combined with clarithromycin

XZP-3287 combined with clarithromycin

Group Type: EXPERIMENTAL

XZP-3287 combined with clarithromycin

Intervention Type: DRUG

Drug: XZP-3287, oral, 120 mg once daily for day 1 and day 12 Drug: clarithromycin, oral, 500 mg twice daily for day 8 to day 21

XZP-3287 combined with rifampicin

XZP-3287 combined with rifampicin

Group Type: EXPERIMENTAL

XZP-3287 combined with rifampicin

Intervention Type: DRUG

Drug: XZP-3287, oral, 360 mg once daily for day 1 and day 14 Drug: rifampicin, oral, 600 mg once daily for day 8 to day 19

Interventions

XZP-3287 combined with clarithromycin

Drug: XZP-3287, oral, 120 mg once daily for day 1 and day 12 Drug: clarithromycin, oral, 500 mg twice daily for day 8 to day 21

Intervention Type: DRUG

XZP-3287 combined with rifampicin

Drug: XZP-3287, oral, 360 mg once daily for day 1 and day 14 Drug: rifampicin, oral, 600 mg once daily for day 8 to day 19

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy male or female subjects aged 18 to 65 years (including 18 and 65);

2. Male body weight ≥50kg, female body weight ≥45kg, body mass index between 18 to 28 kg/m2 (inclusive).

3. No medical history of important primary organ diseases such as nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism and musculoskeletal system.

4. Subjects shall ake effective contraceptive measures voluntarily within 3 months from the date of signing the informed consent form (for women, 2 weeks before trial screening) to the date of the last medication.

5. Willing and able to comply with all scheduled visits, study procedures, and provides written informed consent

Exclusion Criteria

1. Allergic constitution and those with known allergy to XZP-3287 or similar drugs and excipients

2. Abnormal clinical tests and clinical significance judged by the investigator

3. Frequent use of sedatives, sleeping pills or other addictive drugs within 6 months before enrollment

4. History of drug use, or drug abuse screening positive

5. Those who had smoked more than 5 cigarettes per day on average in the 3 months before the screening period or habitually used nicotine-containing products and were unable to quit during the test period

6. Heavy drinking or regular drinking in the six months preceding the screening period

7. Use of any prescription drug or Chinese herbal medicine within 4 weeks prior to enrollment, or use of any over-the-counter drug, any vitamin product, health care drug within 14 days prior to enrollment;

8. Treatment with an investigational drug within 3 months

9. Participated in blood donation with blood donation volume ≥400 mL or received blood transfusion within 3 months before screening.

10. Had a severe infection, trauma or major surgery within 4 weeks of screening

11. Gastrointestinal disorders causing clinically significant symptoms such as nausea, vomiting, and diarrhea, or malabsorption syndromes

12. Pregnant or lactating women, or subjects cannot take strict contraceptive measures as required.

13. Hepatitis B surface antigen or E antigen, hepatitis C antibody, HIV antibody and syphilis antibody, any of which are positive.

14. Allergic to any food ingredients or has special requirements on diet, cannot follow the unified diet

15. habitual consumption of food or beverage containing methylxanthine, such as tea, coffee, cola, chocolate and so on during the study period

16. habitual consumption of grapefruit juice during the study period

17. have difficulty in blood collection or cannot tolerate vein puncture for blood collection

18. As determined by the investigator, the subject has other factors that are not suitable for the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xuanzhu Biopharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhimin Zhou

Role: CONTACT

zhouzhimin@xuanzhubio.com

0086-13647211506

Facility Contacts

Huan Zhou

Role: primary

zhouhuanbest@vip.163.com

0086-0522-3086943

Other Identifiers

XZP-3287-1003

Identifier Type: -

Identifier Source: org_study_id