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