HealthyPhase 1NCT07888569
Assessing the Effect of a Proton Pump Inhibitor on the Pharmacokinetics of DZD8586 in Healthy Participants (TAI-SHAN21)
A Phase 1 study testing DZD8586 and Rabeprazole in people with Healthy, run by Dizal Pharmaceuticals at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- DZD8586 and Rabeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteChina
- Study dates
- 23 Oct 2026to 23 Nov 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- Female and/or male aged 18 ~ 45 years (inclusive), at the time of signing the informed consent.
- Body mass index (BMI) 18~ 30 kg/m^2. Bodyweight of ≥ 45 kg (Female) or ≥ 55 kg (Male).
- Non-smoker (never smoked or > 1 year from the last occurrence of smoking).
- 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.
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- CrCl ≥ 90 mL/min or eGFR ≥ 90 mL/min/1.73m^2.
- 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.
- 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.
Who cannot join
- 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.
- Reported history or any clinically significant abnormalities at the screening of cardiac, hepatic, renal, respiratory, GI, endocrine, immunological, dermatological, hematological, neurological, or psychiatrical disease.
- 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.
- Any infectious diseases.
- History of malignancy of any type, except the following: surgically excised non-melanomatous skin cancers more than 5 years before receiving the Investigational Product.
- Patients who are allergic to or expected to be intolerant to DZD8586, rabeprazole and excipients.
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- 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.
- Have previously completed or withdrawn from this study or any other study investigating DZD8586 and have previously received DZD8586.
- Involvement in the planning and/or conduct of the study (applies to both Dizal staff and/or staff at the study site).
- For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
- Patients who have special dietary requirements and cannot accept the standard diet.
- Patients who cannot tolerate venipuncture or have a history of needle phobia or blood phobia.
- Any alcohol consumption or drug abuse.
- Participation in another clinical study with an investigational product administered in the last 28 days.
- Received a live or live-attenuated vaccine within 3 months before the first dose of the Investigational Product.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029
Shan Jing, 86 13161610502, jingshan@anzhengcp.com
About this study
Official title: A Single-sequence, Open-label, Three-period, Crossover Study to Evaluate the Effect of Rabeprazole, a Proton Pump Inhibitor, on Pharmacokinetics of DZD8586 (Birelentinib) in Healthy Participants
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.
- Conditions
- Healthy
- Being tested
- DZD8586, Rabeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DZD8586Drug
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).
RabeprazoleDrug
Rabeprazole administered by mouth once a day for 7 days in Period 2 and 7 days in Period 3.
| Study group | Role | What they receive |
|---|---|---|
| Single oral dose of DZD8586 | Experimental | Each participant will receive three single doses of DZD8586 without food, with rabeprazole (with food) and with rabeprazole (without food). Receives: Drug: DZD8586; Drug: Rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-inf of DZD8586
area under plasma concentration-time profile from time 0 extrapolated to infinite time for DZD8586
Measured: Up to 120 hours post-dose
AUC0-t of DZD8586
area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration for DZD8586
Measured: Up to 120 hours post-dose
Cmax of DZD8586
observed maximal plasma DZD8586 concentration
Measured: Up to 120 hours post-dose
Secondary outcomes (13)
tmax of DZD8586 and DZ4581
time to the plasma maximal concentration for DZD8586 and its metabolite DZ4581
Measured: Up to 120 hours post-dose
CL/F of DZD8586
apparent clearance for DZD8586
Measured: Up to 120 hours post-dose
t1/2 of DZD8586 and DZ4581
plasma terminal half-life for DZD8586 and its metabolite DZ4581
Measured: Up to 120 hours post-dose
AUC0-inf of DZ4581
area under plasma concentration-time profile from time 0 extrapolated to infinite time for DZ4581
Measured: Up to 120 hours post-dose
AUC0-t of DZ4581
area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration for DZ4581
Measured: Up to 120 hours post-dose
Cmax of DZ4581
observed maximal plasma DZ4581 concentration
Measured: Up to 120 hours post-dose
AUC ratios of DZ4581 to DZD8586 (MRAUC)
Measured: Up to 120 hours post-dose
Cmax ratios of DZ4581 to DZD8586 (MRCmax)
Measured: Up to 120 hours post-dose
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.
Measured: Through study completion, an average of around 2 months.
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.
Measured: Through study completion, an average of around 2 months.
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.
Measured: Through study completion, an average of around 2 months.
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.
Measured: Through study completion, an average of around 2 months.
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.
Measured: Through study completion, an average of around 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start23 Oct 2026
- Primary completion23 Nov 2026 (estimated)
- Study completion23 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Dizal PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888569
- Sponsor's protocol ID
- DZ2025B0005
- Status last verified
- Nov 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-sequence, Open-label, Three-period, Crossover Study to Evaluate the Effect of Rabeprazole, a Proton Pump Inhibitor, on Pharmacokinetics of DZD8586 (Birelentinib) in Healthy Participants
- ClinicalTrials.gov ID
- NCT07888569
- Acronym / sponsor ID
- DZ2025B0005
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2026 (actual)
- Primary completion
- 23 Nov 2026 (estimated)
- Study completion
- 23 Nov 2026 (estimated)
- First posted
- 22 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single oral dose of DZD8586 | Experimental | Drug: DZD8586, Drug: RabeprazoleEach participant will receive three single doses of DZD8586 without food, with rabeprazole (with food) and with rabeprazole (without food). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
- Female and/or male aged 18 ~ 45 years (inclusive), at the time of signing the informed consent.
- Body mass index (BMI) 18~ 30 kg/m^2. Bodyweight of ≥ 45 kg (Female) or ≥ 55 kg (Male).
- Non-smoker (never smoked or > 1 year from the last occurrence of smoking).
- 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.
Key exclusion criteria (20 listed)
- 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.
- Reported history or any clinically significant abnormalities at the screening of cardiac, hepatic, renal, respiratory, GI, endocrine, immunological, dermatological, hematological, neurological, or psychiatrical disease.
- 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.
- Any infectious diseases.
- History of malignancy of any type, except the following: surgically excised non-melanomatous skin cancers more than 5 years before receiving the Investigational Product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DZD8586DZD8586 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). | Drug | Single oral dose of DZD8586 |
| RabeprazoleRabeprazole administered by mouth once a day for 7 days in Period 2 and 7 days in Period 3. | Drug | Single oral dose of DZD8586 |
Primary outcome
AUC0-inf of DZD8586
Time frame: Up to 120 hours post-dose
area under plasma concentration-time profile from time 0 extrapolated to infinite time for DZD8586
AUC0-t of DZD8586
Time frame: Up to 120 hours post-dose
area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration for DZD8586
Cmax of DZD8586
Time frame: Up to 120 hours post-dose
observed maximal plasma DZD8586 concentration
13 secondary outcomes
tmax of DZD8586 and DZ4581
Time frame: Up to 120 hours post-dose
CL/F of DZD8586
Time frame: Up to 120 hours post-dose
t1/2 of DZD8586 and DZ4581
Time frame: Up to 120 hours post-dose
AUC0-inf of DZ4581
Time frame: Up to 120 hours post-dose
AUC0-t of DZ4581
Time frame: Up to 120 hours post-dose
Cmax of DZ4581
Time frame: Up to 120 hours post-dose
AUC ratios of DZ4581 to DZD8586 (MRAUC)
Time frame: Up to 120 hours post-dose
Cmax ratios of DZ4581 to DZD8586 (MRCmax)
Time frame: Up to 120 hours post-dose
Number and percentage of participants with treatment-emergent adverse events (TEAEs) graded by CTCAE v5.0.
Time frame: Through study completion, an average of around 2 months.
Number and percentage of participants with 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.
Number and percentage of participants with clinically significant abnormalities in clinical laboratory tests (including blood chemistry, hematology, coagulation function, and urinalysis).
Time frame: Through study completion, an average of around 2 months.
Number and percentage of participants with clinically significant abnormalities in ECG QTc interval.
Time frame: Through study completion, an average of around 2 months.
Number and percentage of participants with clinically significant abnormalities in other ECG parameters, including RR, PR, QRS.
Time frame: Through study completion, an average of around 2 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DZD8586 and Rabeprazole in people with Healthy, run by Dizal Pharmaceuticals 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 9 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ai (86 021-61098344, Dingding.Ai@dizalpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-inf of DZD8586 (time frame: Up to 120 hours post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2026.