A Drug-drug Interaction Study Evaluating the Pharmacokinetic Effects of Itraconazole or Rifampin or Esomeprazole on XZP-3621 Tablets in Healthy Subjects

Xuanzhu Biopharmaceutical Co., Ltd.1 site in 1 country72 target enrollmentNovember 15, 2022

InterventionsXZP-3621 tablet and itraconazole oral liquid (for Arm1)XZP-3621 tablet and Rifampicin capsules (For Arm 2)XZP-3621 tablet and esomeprazole tablet (For Arm3)

DrugsXZP-3621 tablet and itraconazole oral liquid (for Arm1)XZP-3621 tablet and Rifampicin capsules (For Arm 2)XZP-3621 tablet and esomeprazole tablet (For Arm3)

Overview

Phase: Phase 1
Intervention: XZP-3621 tablet and itraconazole oral liquid (for Arm1)
Conditions: Healthy Subjects
Sponsor: Xuanzhu Biopharmaceutical Co., Ltd.
Enrollment: 72
Locations: 1
Primary Endpoint: Area under the concentration versus time curve of XZP-3621 and its metabolite in plasma (AUC) (Part 1a and Part1b)
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is an open-label, single center, 2 period, one sequence study to investigate the potential drug drug interaction between itraconazole or rifampin or esomeprazole and XZP-3621 tablet.

Registry

clinicaltrials.gov

Start Date

November 15, 2022

End Date

August 2, 2023

Last Updated

3 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Xuanzhu Biopharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male or female subjects aged 18-65 years (including boundary values);
•Male weight ≥50kg, female weight ≥45kg, body mass index (bmi) in the range of 19-28 kg/m2 (including boundary value);
•No mental abnormalities, cardiovascular system, nervous system, respiratory system, digestive system, urinary system, History of systemic, endocrine and metabolic abnormalities;
•The subject and his/her partner agreed to use effective contraception and had no plans to donate sperm or eggs from the time of trial screening until 6 months after the last dose. Women of childbearing age must have a negative blood pregnancy test before the first dose;
•The subjects should be able to communicate well with the researchers, understand and comply with the requirements of the study, and understand and sign the informed consent.

Exclusion Criteria

•Allergy (allergy to two or more substances) or known allergy to XZP-3621 or similar drugs (Group 1 (itraconazole group) excluded patients with history of allergy to itraconazole or similar drugs; group 2 (rifampicin group) excluded patients with allergy to rifampicin or its similar antibacterial drugs); The third group (esomeprazole group) excluded patients with esomeprazole or similar drug allergy history\];
•2.During screening, there are clinical significant abnormal results in Physical examination, laboratory tests, 12-lead electrocardiogram, Anteroposterior and lateral chest x-ray examination or abdomen B ultrasound examination (including thyroid dysfunction with clinical significance)
•Frequent use of sedation, sleeping pills or other addictive drugs within 6 months before enrollment;
•Patients with a history of drug abuse or positive urine drug screening within 12 months before enrollment;
•Smokers who smoked more than 5 cigarettes per day in the 3 months before screening, or who could not stop using any tobacco products during the study;
•Alcohol breath test positive o regular drinkers within 6 months before enrollment, drinking more than 3 units per day, or more than 21 units of alcohol per week(1 unit is equivalent to a 350-ml bottle beer or 120 mL liquor or 30 mL spirits (above 50°)\];
•Use any prescription drugs or traditional Chinese medicine within 4 weeks before enrollment, and/or use any OTC drugs or food supplements (including vitamins, calcium tablets, etc.) within 2 weeks before the first dose;
•Participated in other clinical trials and used investigational drugs within 3 months before enrollment;
•Those who received live vaccine within 2 weeks before the first dose, or planned to receive live vaccine during the study or within 7 days after the study was completed;
•Blood donation or blood loss of 400 mL within 3 months before enrollment, or blood transfusion; Blood donation (including component blood donation) or blood loss of 200 mL within 1 month before enrollment;

Arms & Interventions

XZP-3621 tablet and itraconazole oral liquid

Intervention: XZP-3621 tablet and itraconazole oral liquid (for Arm1)

XZP-3621 tablet and Rifampicin capsules

Intervention: XZP-3621 tablet and Rifampicin capsules (For Arm 2)

XZP-3621 tablet and esomeprazole tablet

Intervention: XZP-3621 tablet and esomeprazole tablet (For Arm3)

Outcomes

Primary Outcomes

Area under the concentration versus time curve of XZP-3621 and its metabolite in plasma (AUC) (Part 1a and Part1b)

Time Frame: Up to nearly 1 month.

To determine the AUC of XZP-3621 and its metabolite.

Maximum serum concentration (Cmax) of XZP-3621 and its metabolite.

Time Frame: Up to nearly 1 week.

To determine the maximum serum concentration (Cmax) of XZP-3621 and its metabolite.

Secondary Outcomes

Severity of adverse events and serious adverse events.(Up to nearly 2 months.)
Serum Half-life (T-HALF) of XZP-3621 and its metabolite .(Up to nearly 1 week.)
Time of Maximum observed serum concentration (Tmax) of XZP-3621 and its metabolite .(Up to nearly 1 week.)
Number of patients with adverse events and serious adverse events.(Up to nearly 2 months.)