nctId: NCT06311786 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 overallStatus: NOT_YET_RECRUITING date: 2024-04-09 date: 2024-05-13 date: 2024-05-13 date: 2024-03-15 date: 2024-03-15 name: Biogen class: INDUSTRY 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. conditions: Healthy Volunteer studyType: INTERVENTIONAL phases: PHASE1 allocation: NA interventionModel: SINGLE_GROUP primaryPurpose: TREATMENT masking: NONE count: 8 type: ESTIMATED name: [14C]-BIIB091 measure: Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu) measure: Amount of BIIB091 Excreted per Sampling Interval in Feces (Aef) measure: Cumulative Amount of BIIB091 Excreted per Sampling Interval in Urine (Cum Aeu) measure: Cumulative Amount of BIIB091 Excreted per Sampling Interval in Feces (Cum Aef) measure: Percentage of BIIB091 Excreted per Sampling Interval in Urine (%Feu) measure: Percentage of BIIB091 Excreted per Sampling Interval in Feces (%Fef) measure: Cumulative Percentage of BIIB091 Excreted in Urine (Cum %Feu) measure: Cumulative Percentage of BIIB091 Excreted in Feces (Cum %Fef) measure: Maximum Observed Concentration (Cmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood measure: Time to Reach Maximum Observed Concentration (Tmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood 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 measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood measure: Terminal Half-Life (t1/2) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood measure: Apparent Clearance (CL/F) of BIIB091 in Plasma measure: Apparent Volume of Distribution (Vz/F) of BIIB091 in Plasma measure: Quantitative Profile of [14C]-BIIB091 Metabolites in Plasma measure: Quantitative Profile of [14C]-BIIB091 Metabolites in Urine measure: Quantitative Profile of [14C]-BIIB091 Metabolites in Feces measure: Cmax of Plasma Metabolite 23 (M23) measure: Tmax of Plasma M23 measure: AUClast of Plasma M23 measure: AUCinf of Plasma M23 measure: t1/2 of Plasma M23 measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters measure: Number of Participants With Clinically Significant Vital Sign Abnormalities measure: Number of Participants With Clinically Significant Physical Examination Abnormalities measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities as Assessed by 12-Lead ECG Measurements measure: Number of Participants With Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score sex: MALE minimumAge: 18 Years maximumAge: 55 Years stdAges: ADULT hasResults: False