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
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.
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.
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.
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.
Exclusion Criteria:
Any of the following medical conditions:
Each participant will receive three single doses of DZD8586 without food, with rabeprazole (with food) and with rabeprazole (without food).
Drug: DZD8586 · Drug: Rabeprazole
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.
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
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
Cmax of DZD8586
observed maximal plasma DZD8586 concentration
Time frame: Up to 120 hours post-dose
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
CL/F of DZD8586
apparent clearance for DZD8586
Time frame: Up to 120 hours post-dose
t1/2 of DZD8586 and DZ4581
plasma terminal half-life for DZD8586 and its metabolite DZ4581
Time frame: 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
Time frame: 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
Time frame: Up to 120 hours post-dose
Cmax of DZ4581
observed maximal plasma DZ4581 concentration
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.
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.
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.
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.
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.
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.
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 ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Birelentinib · Rabeprazole