protocolSection identificationModule nctId: NCT06368440, orgStudyIdInfo id: D7860C00003, briefTitle: A Study to Investigate the Safety and Pharmacokinetics of AZD6793 in Healthy Japanese and Chinese Participants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-15, primaryCompletionDateStruct date: 2024-10-04, completionDateStruct date: 2024-10-04, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral AZD6793 in healthy Japanese and Chinese participants., conditionsModule conditions: Healthy Participants, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: OTHER, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: AZD6793, interventions name: AZD6793, interventions name: Placebo, outcomesModule primaryOutcomes measure: Part 1 (SAD): Number of Participants with Adverse Events, primaryOutcomes measure: Part 2 (MAD): Number of Participants with Adverse Events, secondaryOutcomes measure: Part 1 (SAD) : Maximum Observed Plasma Drug Concentration, secondaryOutcomes measure: Part 1 (SAD): Time to Reach Peak Concentration (tmax), secondaryOutcomes measure: Part 1 (SAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (λz), secondaryOutcomes measure: Part 1 (SAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz), secondaryOutcomes measure: Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 12 (AUC[0-12]), secondaryOutcomes measure: Part 1 (SAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24]), secondaryOutcomes measure: Part 1 (SAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast), secondaryOutcomes measure: Part 1 (SAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf), secondaryOutcomes measure: Part 1 (SAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F), secondaryOutcomes measure: Part 1 (SAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F), secondaryOutcomes measure: Part 1 (SAD): Dose Normalized AUClast, secondaryOutcomes measure: Part 1 (SAD): Dose Normalized AUCinf, secondaryOutcomes measure: Part 1 (SAD): Dose Normalized Cmax, secondaryOutcomes measure: Part 2 (MAD): Maximum Observed Plasma Drug Concentration (Cmax), secondaryOutcomes measure: Part 2 (MAD) : Concentration at the End of The Dosing Interval (Ctrough), secondaryOutcomes measure: Part 2 (MAD): Temporal Change Parameter (TCP), secondaryOutcomes measure: Part 2 (MAD): Time to Reach Peak Concentration (tmax), secondaryOutcomes measure: Part 2 (MAD): Terminal Rate Constant, Estimated by Log-Linear Least Squares Regression of the Terminal Part of The Concentration-Time Curve (λz), secondaryOutcomes measure: Part 2 (MAD): Half-life Associated with Terminal Slope of a Semi-Logarithmic Concentration-Time Curve (t1/2λz), secondaryOutcomes measure: Part 2 (MAD): Partial Area Under the Plasma Concentration Time Curve from Time Zero to Time 24 (AUC[0-24]), secondaryOutcomes measure: Part 2 (MAD): Area Under the Plasma Concentration Curve from Time Zero to the Last Quantifiable Concentration (AUClast), secondaryOutcomes measure: Part 2 (MAD): Area Under the Plasma Concentration Time Curve from Time Zero to Infinity (AUCinf), secondaryOutcomes measure: Part 2 (MAD): Area Under Plasma Concentration-Time Curve in The Dosing Interval Tau (AUCtau), secondaryOutcomes measure: Part 2 (MAD): Apparent Total Body Clearance of Drug from Plasma After Extravascular Administration (CL/F), secondaryOutcomes measure: Part 2 (MAD): Volume of Distribution (Apparent) at Steady State Following Extravascular Administration (Vz/F), secondaryOutcomes measure: Part 2 (MAD): Dose Normalized AUClast, secondaryOutcomes measure: Part 2 (MAD): Dose Normalized AUCtau, secondaryOutcomes measure: Part 2 (MAD): Dose Normalized Cmax, secondaryOutcomes measure: Part 2 (MAD): Ratio of the Area Under the Curve (Rac AUC), secondaryOutcomes measure: Part 2 (MAD): Accumulation Ratio Based on Cmax (Rac Cmax), secondaryOutcomes measure: Part 2 (MAD): Amount of Unchanged Drug Excreted into Urine from Time t1 to Time t2 (Ae[t1-t2]), secondaryOutcomes measure: Part 2 (MAD): Cumulative Amount of Unchanged Drug Excreted into Urine (Aeinf), secondaryOutcomes measure: Part 2 (MAD): Renal Clearance (CLR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Research Site, city: Glendale, state: California, zip: 91206, country: United States, geoPoint lat: 34.14251, lon: -118.25508, hasResults: False