Drug-drug Interaction Study of XZP-3621 Tablet

NCT05586568 | Unknown Phase 1

• 1 other identifier: XZP-3621-1003
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (2)

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

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

  Up to nearly 1 month.

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

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

  Up to nearly 1 week.

Secondary Outcomes (4)

• Time of Maximum observed serum concentration (Tmax) of XZP-3621 and its metabolite .

  Up to nearly 1 week.

• Serum Half-life (T-HALF) 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.

• Severity of adverse events and serious adverse events.

  Up to nearly 2 months.

Study Arms (3)

XZP-3621 tablet and itraconazole oral liquid

EXPERIMENTAL

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

XZP-3621 tablet and Rifampicin capsules

EXPERIMENTAL

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

XZP-3621 tablet and esomeprazole tablet

EXPERIMENTAL

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

Interventions

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

There are 2 periods, for the 1st period, the subjects will only take XZP-3621 tablets QD on Day1. For period 2,the subjects will take itraconazole from Day11 to Day13，they will take itraconazole in combinaiton with XZP-3621 on Day14，then take itraconazole only, from Day15 to Day27.

XZP-3621 tablet and itraconazole oral liquid

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

There are 2 periods, for the 1st period, the subjects will only take XZP-3621 tablets qd on Day1 . For period 2,the subjects will take Rifampicin from Day11 to Day17，they will take Rifampicin in combinaiton with XZP-3621 on day18，then take Rifampicin only, from Day19 to Day26.

XZP-3621 tablet and Rifampicin capsules

XZP-3621 tablet and esomeprazole tablet (For Arm3) DRUG

There are 2 periods, for the 1st period, the subjects will only take XZP-3621 tablets QD on Day1 . For period 2,the subjects will take esomeprazole from Day11 to Day 15，they will take esomeprazole in combinaiton with XZP-3621 on Day16.

XZP-3621 tablet and esomeprazole tablet

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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\];
• 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;
• \. Have a history of major disease or major surgery or trauma within 3 months before screening;
• \. Gastrointestinal disease causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome, or a history of severe vomiting or diarrhea within one week before enrollment;
• \. Female subjects during pregnancy and lactation and female subjects of reproductive age who cannot take contraception as required;
• \. HBsAg, HCV Ab, Treponema pallidum antibody, HIV Ab test results are positive;
• \. Those who have special dietary requirements (including lactose intolerance) and are unable to comply with the provided diet and corresponding regulations;

Sponsors & Collaborators

• Xuanzhu Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

MeSH Terms

Interventions

Rifampin; Esomeprazole

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Heterocyclic Compounds, 2-Ring

Study Officials

• Yu Cao

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ninghua Zhu

CONTACT

+86-13910648041; zhuninghua@xuanzhubio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2022
• First Posted: October 19, 2022
• Study Start: November 15, 2022
• Primary Completion: April 5, 2023
• Study Completion: August 2, 2023
• Last Updated: October 19, 2022

Record last verified: 2022-08

Locations

CN (1)