protocolSection identificationModule nctId: NCT06268301, orgStudyIdInfo id: TAK-721-1003, briefTitle: A Study to Determine the Effect Food Has on TAK-721 (Budesonide Oral Suspension) in the Body of Healthy Adults, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-02-06, primaryCompletionDateStruct date: 2023-02-17, completionDateStruct date: 2023-02-20, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Takeda, class: INDUSTRY, descriptionModule briefSummary: The main aim of this study is to check what the body of a healthy adult who either fasted or had eaten does to TAK-721 and how TAK-721 is distributed in and removed from the body. Other aims are to learn how safe the treatment with TAK-721 is and how suitable the TAK-721 is for healthy adults who either fasted or had eaten. All participants will receive TAK-721 but half will be assigned by chance to the participant group who are fasting first then getting the high-fat/high-calorie meal later or the group who gets meal first and fasts later. The group assignment will be switched once during the course of the study so that all participants will receive TAK-721 in both a fasted or fed condition., conditionsModule conditions: Healthy Volunteers, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Budesonide, outcomesModule primaryOutcomes measure: Maximum Observed Concentration (Cmax), primaryOutcomes measure: Area Under the Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast), primaryOutcomes measure: Area Under the Concentration-time Curve From Time 0 to Infinity (AUC∞), secondaryOutcomes measure: Number of Participants who Experience at Least one Treatment Emergent Adverse Event (TEAE) by Severity, Serious Adverse Events (SAE) and Death, secondaryOutcomes measure: Number of Participants With Clinically Significant Abnormal Vital Sign Values, secondaryOutcomes measure: Number of Participants With Clinically Significant Abnormal Clinical Laboratory Values, secondaryOutcomes measure: Area Under the Concentration-time Curve From Time 0 to 12 Hours (AUC0-12), secondaryOutcomes measure: Area Under the Curve From the Last Quantifiable Concentration to Infinity Expressed as a Percentage of AUC∞ (AUCextrap%), secondaryOutcomes measure: Time to First Occurrence of Cmax (tmax), secondaryOutcomes measure: Lag Time to First Quantifiable Concentration (tlag), secondaryOutcomes measure: Terminal Disposition Phase Half-life (t1/2z), secondaryOutcomes measure: Terminal Disposition Phase Rate Constant (λz)., secondaryOutcomes measure: Apparent Clearance (CL/F) Calculated Using the Observed Value of the Last Quantifiable Concentration, secondaryOutcomes measure: Apparent Volume of Distribution During the Terminal Disposition Phase (Vz/F) Calculated Using the Observed Value of the Last Quantifiable Concentration, eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Celerion, city: Lincoln, state: Nebraska, zip: 68502, country: United States, geoPoint lat: 40.8, lon: -96.66696, hasResults: False