Registered outcomes16

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 16 of 16

List	Outcome	Time frame	Description
Primary	AUC0-inf of DZD8586	Up to 120 hours post-dose	area under plasma concentration-time profile from time 0 extrapolated to infinite time for DZD8586
Primary	AUC0-t of DZD8586	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
Primary	Cmax of DZD8586	Up to 120 hours post-dose	observed maximal plasma DZD8586 concentration
Secondary	tmax of DZD8586 and DZ4581	Up to 120 hours post-dose	time to the plasma maximal concentration for DZD8586 and its metabolite DZ4581
Secondary	CL/F of DZD8586	Up to 120 hours post-dose	apparent clearance for DZD8586
Secondary	t1/2 of DZD8586 and DZ4581	Up to 120 hours post-dose	plasma terminal half-life for DZD8586 and its metabolite DZ4581
Secondary	AUC0-inf of DZ4581	Up to 120 hours post-dose	area under plasma concentration-time profile from time 0 extrapolated to infinite time for DZ4581
Secondary	AUC0-t of DZ4581	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 DZ4581
Secondary	Cmax of DZ4581	Up to 120 hours post-dose	observed maximal plasma DZ4581 concentration
Secondary	AUC ratios of DZ4581 to DZD8586 (MRAUC)	Up to 120 hours post-dose
Secondary	Cmax ratios of DZ4581 to DZD8586 (MRCmax)	Up to 120 hours post-dose
Secondary	Number and percentage of participants with treatment-emergent adverse events (TEAEs) graded by CTCAE v5.0.	Through study completion, an average of around 2 months.	To assess TEAEs, including serious TEAEs and TEAEs leading to discontinuation, graded by CTCAE v5.0.
Secondary	Number and percentage of participants with clinically significant abnormalities in vital signs (including pulse rate, blood pressure and heart rate).	Through study completion, an average of around 2 months.	To assess clinically significant abnormalities in vital signs, including pulse rate, blood pressure and heart rate.
Secondary	Number and percentage of participants with clinically significant abnormalities in clinical laboratory tests (including blood chemistry, hematology, coagulation function, and urinalysis).	Through study completion, an average of around 2 months.	To assess clinically significant abnormalities in clinical laboratory tests.
Secondary	Number and percentage of participants with clinically significant abnormalities in ECG QTc interval.	Through study completion, an average of around 2 months.	To assess clinically significant QT/QTc abnormalities, including QTc \>450 msec, \>480 msec, \>500 msec, and increase from baseline \>60 msec.
Secondary	Number and percentage of participants with clinically significant abnormalities in other ECG parameters, including RR, PR, QRS.	Through study completion, an average of around 2 months.	To assess clinically significant abnormalities in other ECG parameters, including RR, PR, QRS.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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