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Not yet recruitingNCT07888569Updated Oct 22, 2026

Assessing the Effect of a Proton Pump Inhibitor on the Pharmacokinetics of DZD8586 in Healthy Participants (TAI-SHAN21)

A Phase 1 interventional study of DZD8586 and Rabeprazole in Healthy, sponsored by Dizal Pharmaceuticals. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Dizal Pharmaceuticals · Phase 1, Interventional, and Treatment

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This study is a phase 1, open-label, three-period crossover study to evaluate the effect of Rabeprazole, a proton pump inhibitor, on the pharmacokinetics of DZD8586 (Birelentinib) under fasted and fed conditions in healthy participants.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Dizal Pharmaceuticals is the lead sponsor of 39 studies on the registry; 15 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 1 (7%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Participants must be able to understand the nature of the trial and provide a signed and dated, written informed consent form before any study-specific procedures, sampling, and analyses.
  2. Female and/or male aged 18 \~ 45 years (inclusive), at the time of signing the informed consent.
  3. Body mass index (BMI) 18\~ 30 kg/m\^2. Bodyweight of ≥ 45 kg (Female) or ≥ 55 kg (Male).
  4. Non-smoker (never smoked or > 1 year from the last occurrence of smoking).
  5. Participants are healthy as determined by vital signs, physical examination, clinical laboratory tests, 12-lead electrocardiogram, HBV, HCV, HIV, TB, performed before the first administration of the study drug, including the following criteria.

    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< ULN (Upper Limit of Normal); Total Bilirubin \< ULN.
    • CrCl ≥ 90 mL/min or eGFR ≥ 90 mL/min/1.73m\^2.
  6. Male participants must be surgically sterile or using an acceptable method of contraception during the study (from the time they sign consent) and for 30 days after the last dose of the Investigational Product to prevent pregnancy with a partner. Abstinence is an acceptable form of contraception, provided that the participant agrees to use barrier methods in conjunction with spermicides if they do engage in sexual intercourse.
  7. Female participants must have negative pregnancy tests at screening and check-in AND: have been surgically sterile OR post-menopausal and serum estradiol at screening OR, if of child-bearing potential, must be using an acceptable method of contraception for the last three months. All females must agree to continue using their contraceptive method throughout the study period and for 30 days after the last dose of investigational product.

Exclusion criteria

Exclusion Criteria:

  1. Any condition which in the opinion of the investigator would interfere with the participant's ability to provide informed consent, comply with study instructions, confound interpretation of study results, or endanger the participant if he or she takes part in the trial.
  2. Reported history or any clinically significant abnormalities at the screening of cardiac, hepatic, renal, respiratory, GI, endocrine, immunological, dermatological, hematological, neurological, or psychiatrical disease.
  3. Any cardiovascular abnormity or bleeding disorder. For example, during the screening period, the average resting corrected QTcF interval (QTC) on the electrocardiogram (ECG) was > 450 msec for male and female.
  4. Any infectious diseases.
  5. History of malignancy of any type, except the following: surgically excised non-melanomatous skin cancers more than 5 years before receiving the Investigational Product.
  6. Patients who are allergic to or expected to be intolerant to DZD8586, rabeprazole and excipients.
  7. Any of the following medical conditions:

    • Underwent any major surgery within 4 weeks prior to screening.
    • Has donated blood (including blood products) or experienced loss of blood ≥ 500 mL within 2 months before screening.
    • Has intractable nausea, vomiting, or chronic gastrointestinal disease.
    • Has a history of severe allergic or hypersensitivity reaction; or is currently experiencing an allergic or hypersensitivity reaction.
  8. Have previously completed or withdrawn from this study or any other study investigating DZD8586 and have previously received DZD8586.
  9. Involvement in the planning and/or conduct of the study (applies to both Dizal staff and/or staff at the study site).
  10. For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
  11. Patients who have special dietary requirements and cannot accept the standard diet.
  12. Patients who cannot tolerate venipuncture or have a history of needle phobia or blood phobia.
  13. Any alcohol consumption or drug abuse.
  14. Participation in another clinical study with an investigational product administered in the last 28 days.
  15. Received a live or live-attenuated vaccine within 3 months before the first dose of the Investigational Product.
  16. Any of the foods, drugs, or products that may affect or potentially affect the investigational drug has been taken before screening or investigational product administration.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (estimated)

Study arms

  • Experimental
    Single oral dose of DZD8586

    Each participant will receive three single doses of DZD8586 without food, with rabeprazole (with food) and with rabeprazole (without food).

    Drug: DZD8586 · Drug: Rabeprazole

Interventions

  • DZD8586 administered by mouth as a single dose in Period 1 (without food), Period 2 (with rabeprazole with food) and Period 3 (with rabeprazole without food).

  • Rabeprazole administered by mouth once a day for 7 days in Period 2 and 7 days in Period 3.

06

What researchers measure

Primary outcomes

  1. AUC0-inf of DZD8586

    area under plasma concentration-time profile from time 0 extrapolated to infinite time for DZD8586

    Time frame: Up to 120 hours post-dose

  2. AUC0-t of DZD8586

    area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration for DZD8586

    Time frame: Up to 120 hours post-dose

  3. Cmax of DZD8586

    observed maximal plasma DZD8586 concentration

    Time frame: Up to 120 hours post-dose

Secondary outcomes

  1. tmax of DZD8586 and DZ4581

    time to the plasma maximal concentration for DZD8586 and its metabolite DZ4581

    Time frame: Up to 120 hours post-dose

  2. CL/F of DZD8586

    apparent clearance for DZD8586

    Time frame: Up to 120 hours post-dose

  3. t1/2 of DZD8586 and DZ4581

    plasma terminal half-life for DZD8586 and its metabolite DZ4581

    Time frame: Up to 120 hours post-dose

  4. AUC0-inf of DZ4581

    area under plasma concentration-time profile from time 0 extrapolated to infinite time for DZ4581

    Time frame: Up to 120 hours post-dose

  5. AUC0-t of DZ4581

    area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration for DZ4581

    Time frame: Up to 120 hours post-dose

  6. Cmax of DZ4581

    observed maximal plasma DZ4581 concentration

    Time frame: Up to 120 hours post-dose

  7. AUC ratios of DZ4581 to DZD8586 (MRAUC)

    Time frame: Up to 120 hours post-dose

  8. Cmax ratios of DZ4581 to DZD8586 (MRCmax)

    Time frame: Up to 120 hours post-dose

  9. Number and percentage of participants with treatment-emergent adverse events (TEAEs) graded by CTCAE v5.0.

    To assess TEAEs, including serious TEAEs and TEAEs leading to discontinuation, graded by CTCAE v5.0.

    Time frame: Through study completion, an average of around 2 months.

  10. Number and percentage of participants with clinically significant abnormalities in vital signs (including pulse rate, blood pressure and heart rate).

    To assess clinically significant abnormalities in vital signs, including pulse rate, blood pressure and heart rate.

    Time frame: Through study completion, an average of around 2 months.

  11. Number and percentage of participants with clinically significant abnormalities in clinical laboratory tests (including blood chemistry, hematology, coagulation function, and urinalysis).

    To assess clinically significant abnormalities in clinical laboratory tests.

    Time frame: Through study completion, an average of around 2 months.

  12. Number and percentage of participants with clinically significant abnormalities in ECG QTc interval.

    To assess clinically significant QT/QTc abnormalities, including QTc \>450 msec, \>480 msec, \>500 msec, and increase from baseline \>60 msec.

    Time frame: Through study completion, an average of around 2 months.

  13. Number and percentage of participants with clinically significant abnormalities in other ECG parameters, including RR, PR, QRS.

    To assess clinically significant abnormalities in other ECG parameters, including RR, PR, QRS.

    Time frame: Through study completion, an average of around 2 months.

07

Study locations

1 site
  • Beijing Anzhen Hospital, Capital Medical University
    Beijing, Beijing Municipality 100029, China
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07888569
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Oct 16, 2026 (estimated)
Primary completion
Nov 23, 2026 (estimated)
Completion
Nov 23, 2026 (estimated)
Last update
Oct 22, 2026

Study contacts

Ai
Contact
Dingding.Ai@dizalpharma.com
86 021-61098344

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Birelentinib · Rabeprazole

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