protocolSection identificationModule nctId: NCT06381466, orgStudyIdInfo id: D7250C00001, briefTitle: A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral AZD0233 Compared With Placebo in Healthy Adult Participants., statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-03-20, completionDateStruct date: 2025-03-20, studyFirstPostDateStruct date: 2024-04-24, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: AstraZeneca, class: INDUSTRY, collaborators name: Parexel, descriptionModule briefSummary: The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of AZD0233 following single and multiple ascending dose (SAD and MAD) administration in healthy participants., conditionsModule conditions: Dilated Cardiomyopathy, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 96, type: ESTIMATED, armsInterventionsModule interventions name: AZD0233, interventions name: AZD0233 Placebo, outcomesModule primaryOutcomes measure: Number of participants with adverse events (AEs) and serious adverse events (SAEs), secondaryOutcomes measure: Maximum observed plasma (peak) drug concentration (Cmax) of AZD0233, secondaryOutcomes measure: Area under the plasma concentration-curve from zero to the last quantifiable concentration (AUClast) of AZD0233, secondaryOutcomes measure: Area under the concentration-time curve in the dose interval (AUCtau) of AZD0233, secondaryOutcomes measure: Area under plasma concentration time-curve from zero to infinity (AUCinf) of AZD0233, secondaryOutcomes measure: Time to reach peak or maximum observed concentration or response following drug administration (tmax) of AZD0233, secondaryOutcomes measure: Terminal elimination half-life (t1/2) of AZD0233, secondaryOutcomes measure: Apparent total body clearance of drug from plasma after extravascular administration (CL/F) of AZD0233, secondaryOutcomes measure: Apparent volume of distribution at steady state following extravascular administration (Vz/F) of AZD0233, secondaryOutcomes measure: Terminal rate constant (λz) of AZD0233, secondaryOutcomes measure: Accumulation ratio for Cmax (Rac Cmax) of AZD0233, secondaryOutcomes measure: Accumulation ratio for AUC (Rac AUC) of AZD0233, secondaryOutcomes measure: Renal clearance (CLR) of AZD0233, secondaryOutcomes measure: Cumulative amount of unchanged drug excreted into urine from time t1 to time t2 [Ae(t1-t2)] of AZD0233, secondaryOutcomes measure: Cumulative amount of unchanged drug excreted into urine (Aeinf) of AZD0233, secondaryOutcomes measure: Percentage of dose excreted unchanged in urine from time t1 to t2 [Fe(t1-t2)] of AZD0233, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: Research Site, status: RECRUITING, city: Glendale, state: California, zip: 91206, country: United States, geoPoint lat: 34.14251, lon: -118.25508, hasResults: False