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
NCT ID NCT07888569
First seen Oct 22, 2026 · Last updated Oct 22, 2026
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 26 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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: 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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, 100029, China
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