protocolSection identificationModule nctId: NCT06311786, orgStudyIdInfo id: 257HV107, briefTitle: A Study to Look at How a Single Oral Dose of Carbon-14-Labelled [14C] BIIB091 Moves Through and is Processed by the Body in Healthy Male Participants, acronym: Mass Balance, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-09, primaryCompletionDateStruct date: 2024-05-13, completionDateStruct date: 2024-05-13, studyFirstPostDateStruct date: 2024-03-15, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Biogen, class: INDUSTRY, descriptionModule briefSummary: The main goal of this study is to learn how \[14C\]-BIIB091 moves through and is processed by the body and to look at how much of BIIB091's metabolites (what is produced when BIIB091 is broken down by the body) appears in the blood, urine, and stool in healthy male participants. The study will also help researchers learn more about the safety of BIIB091 in healthy male participants., conditionsModule conditions: Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 8, type: ESTIMATED, armsInterventionsModule interventions name: [14C]-BIIB091, outcomesModule primaryOutcomes measure: Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu), primaryOutcomes measure: Amount of BIIB091 Excreted per Sampling Interval in Feces (Aef), primaryOutcomes measure: Cumulative Amount of BIIB091 Excreted per Sampling Interval in Urine (Cum Aeu), primaryOutcomes measure: Cumulative Amount of BIIB091 Excreted per Sampling Interval in Feces (Cum Aef), primaryOutcomes measure: Percentage of BIIB091 Excreted per Sampling Interval in Urine (%Feu), primaryOutcomes measure: Percentage of BIIB091 Excreted per Sampling Interval in Feces (%Fef), primaryOutcomes measure: Cumulative Percentage of BIIB091 Excreted in Urine (Cum %Feu), primaryOutcomes measure: Cumulative Percentage of BIIB091 Excreted in Feces (Cum %Fef), primaryOutcomes measure: Maximum Observed Concentration (Cmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood, primaryOutcomes measure: Time to Reach Maximum Observed Concentration (Tmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood, primaryOutcomes measure: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Measurable Concentration (AUClast) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood, primaryOutcomes measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood, primaryOutcomes measure: Terminal Half-Life (t1/2) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood, primaryOutcomes measure: Apparent Clearance (CL/F) of BIIB091 in Plasma, primaryOutcomes measure: Apparent Volume of Distribution (Vz/F) of BIIB091 in Plasma, primaryOutcomes measure: Quantitative Profile of [14C]-BIIB091 Metabolites in Plasma, primaryOutcomes measure: Quantitative Profile of [14C]-BIIB091 Metabolites in Urine, primaryOutcomes measure: Quantitative Profile of [14C]-BIIB091 Metabolites in Feces, secondaryOutcomes measure: Cmax of Plasma Metabolite 23 (M23), secondaryOutcomes measure: Tmax of Plasma M23, secondaryOutcomes measure: AUClast of Plasma M23, secondaryOutcomes measure: AUCinf of Plasma M23, secondaryOutcomes measure: t1/2 of Plasma M23, secondaryOutcomes measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters, secondaryOutcomes measure: Number of Participants With Clinically Significant Vital Sign Abnormalities, secondaryOutcomes measure: Number of Participants With Clinically Significant Physical Examination Abnormalities, secondaryOutcomes measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities as Assessed by 12-Lead ECG Measurements, secondaryOutcomes measure: Number of Participants With Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score, eligibilityModule sex: MALE, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False