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Healthy SubjectsPhase 1NCT05586568

Drug-drug Interaction Study of XZP-3621 Tablet

A Phase 1 study testing XZP-3621 tablet and itraconazole oral liquid (for Arm1), XZP-3621 tablet and Rifampicin capsules (For Arm 2) and XZP-3621 tablet and esomeprazole tablet (For Arm3) in people with Healthy Subjects, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Subjects
What is being tested?
XZP-3621 tablet and itraconazole oral liquid (for Arm1), XZP-3621 tablet and Rifampicin capsules (For Arm 2) and XZP-3621 tablet and esomeprazole tablet (For Arm3)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteChina
Study dates
15 Nov 2022to 2 Aug 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 1. 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)
  • 3. Frequent use of sedation, sleeping pills or other addictive drugs within 6 months before enrollment;
  • 4. Patients with a history of drug abuse or positive urine drug screening within 12 months before enrollment;
  • 5. 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;
  • 6. 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°)];
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  • 7. 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;
  • 8. Participated in other clinical trials and used investigational drugs within 3 months before enrollment;
  • 9. 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;
  • 10. 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;
  • 11. Have a history of major disease or major surgery or trauma within 3 months before screening;
  • 12. 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;
  • 13. Female subjects during pregnancy and lactation and female subjects of reproductive age who cannot take contraception as required;
  • 14. HBsAg, HCV Ab, Treponema pallidum antibody, HIV Ab test results are positive;
  • 15. Those who have special dietary requirements (including lactose intolerance) and are unable to comply with the provided diet and corresponding regulations;
  • 16. Subjects refused to discontinue any beverage or food containing xanthine derivatives, such as caffeine (coffee, tea, cola, chocolate, etc.) for 48 hours before the first dose and until the end of the study;
  • 17. Use of any drug that inhibits or induces hepatic metabolism (inducer) within 30 days prior to the first dose such as: barbiturates, carbamazepine, phenytoin sodium, rifamequine; Inhibitors such as cimetidine, Cyclosporine, macrolides, verapamil, quinolones, pyrroles, etc.);
  • 18. Use of proton pump inhibitor (PPI) drugs within 7 days before the first dose(eg: Rabeprazole, pantoprazole, esomeprazole, etc.).
  • 19. Ingested or planned ingestion of grapefruit or grapefruit-related citrus within 14 days before the first dose Fruit (such as lime, grapefruit), star fruit, papaya, pomegranate or above fruit products;
  • 20. Those who cannot tolerate blood collection by venipuncture or whose blood vessels are in poor condition;
  • 21. Other subjects deemed unsuitable to participate in the study by the investigator.

Trial locations and contacts

1 site in 1 country.

Ninghua Zhu contact

+86-13910648041

zhuninghua@xuanzhubio.com

China1 site

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

    Yu Cao, Doctor, +86-0532-82911767, Caoyu1767@126.com

Other trials in China

About this study

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

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.

Being tested
XZP-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)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 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 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.

Study groups in NCT05586568
Study groupRoleWhat they receive
XZP-3621 tablet and itraconazole oral liquidExperimentalNot described
Receives: Drug: XZP-3621 tablet and itraconazole oral liquid (for Arm1)
XZP-3621 tablet and Rifampicin capsulesExperimentalNot described
Receives: Drug: XZP-3621 tablet and Rifampicin capsules (For Arm 2)
XZP-3621 tablet and esomeprazole tabletExperimentalNot described
Receives: Drug: XZP-3621 tablet and esomeprazole tablet (For Arm3)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to nearly 1 month.

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

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

    Measured: Up to nearly 1 week.

Secondary outcomes (4)

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

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

    Measured: Up to nearly 1 week.

  2. Serum Half-life (T-HALF) of XZP-3621 and its metabolite .

    To determine the t1/2 of XZP-3621 and its metabolite .

    Measured: Up to nearly 1 week.

  3. Number of patients with adverse events and serious adverse events.

    Number of patients who experienced an adverse event or serious adverse events.

    Measured: Up to nearly 2 months.

  4. Severity of adverse events and serious adverse events.

    Severity of the adverse events or serious adverse events.

    Measured: Up to nearly 2 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2022
  2. Study start15 Nov 2022 (estimated)
  3. Primary completion5 Apr 2023 (estimated)
  4. Study completion2 Aug 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05586568
Sponsor's protocol ID
XZP-3621-1003
Status last verified
Aug 2022
First submitted
16 Oct 2022
Last updated
19 Oct 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fang L, Jiang X, Song K, Shi P, Wang L, Xu L, Duan X, Liu F, Sun F, Ban R, Ma Y, Wang C, Cao Y. Presence of drug-drug interactions between esomeprazole and an ALK tyrosine kinase inhibitor (Dirozalkib). Cancer Chemother Pharmacol. 2025 Dec 5;95(1):122. doi: 10.1007/s00280-025-04837-x.

    PubMed 41348226

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing XZP-3621 tablet and itraconazole oral liquid (for Arm1), XZP-3621 tablet and Rifampicin capsules (For Arm 2) and XZP-3621 tablet and esomeprazole tablet (For Arm3) in people with Healthy Subjects, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ninghua Zhu (+86-13910648041, zhuninghua@xuanzhubio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05586568, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.

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