Proton pump inhibitor effect on a cancer-related drug in healthy people
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
Run by Dizal Pharmaceuticals · NCT07888569 · Data updated 2026-11-12
This early-phase study tests whether rabeprazole changes how the drug DZD8586 behaves in the body, in healthy adult volunteers.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Enrollment | 26 (estimated) |
| Sponsor | Dizal Pharmaceuticals Industry-sponsored |
| Drugs / interventions | Birelentinib |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Status | Recruiting |
| Started | October 23, 2026 |
| Main results expected | November 23, 2026 |
| Study ends | November 23, 2026 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07888569 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are healthy adults aged 18–45 with BMI 18–30, non-smokers, normal labs and kidney function, and who are willing to adhere to study procedures.
✕Probably not a fit
People with underlying medical conditions, abnormal lab tests, or recent smoking history are unlikely to benefit and may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 1, open-label, three-period crossover study designed to measure how rabeprazole affects the pharmacokinetics of DZD8586 in healthy participants under fasted and fed conditions. Participants will receive DZD8586 alone and with rabeprazole across three treatment periods, with careful sampling to compare drug exposure. The trial aims to understand potential drug–drug interactions before broader patient testing. It is conducted at a single center in Beijing and involves rigorous safety monitoring and inclusion criteria to ensure healthy volunteers. The study helps determine if dose adjustments or timing are needed when these drugs are used together.
Why it matters
Potential benefit: Participants may not directly benefit, but the information could improve future prescribing guidance for this drug combination.
How similar studies have gone: Similar drug–drug interaction studies in healthy volunteers have helped guide dosing and labeling for other drug combinations.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Beijing Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China Recruiting
Study contacts
- Study coordinator: Ai
- Email: Dingding.Ai@dizalpharma.com
- Phone: 86 021-61098344
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.