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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Administered as specified in the treatment arm.
PPD Clinical Research Unit
Austin, Texas, United States
Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu)
Time frame: Pre-dose and at multiple timepoints up to Day 10
Amount of BIIB091 Excreted per Sampling Interval in Feces (Aef)
Time frame: Pre-dose and at multiple timepoints up to Day 10
Cumulative Amount of BIIB091 Excreted per Sampling Interval in Urine (Cum Aeu)
Time frame: Pre-dose and at multiple timepoints up to Day 10
Cumulative Amount of BIIB091 Excreted per Sampling Interval in Feces (Cum Aef)
Time frame: Pre-dose and at multiple timepoints up to Day 10
Percentage of BIIB091 Excreted per Sampling Interval in Urine (%Feu)
Time frame: Pre-dose and at multiple timepoints up to Day 10
Percentage of BIIB091 Excreted per Sampling Interval in Feces (%Fef)
Time frame: Pre-dose and at multiple timepoints up to Day 10
Cumulative Percentage of BIIB091 Excreted in Urine (Cum %Feu)
Time frame: Pre-dose and at multiple timepoints up to Day 10
Cumulative Percentage of BIIB091 Excreted in Feces (Cum %Fef)
Time frame: Pre-dose and at multiple timepoints up to Day 10
Maximum Observed Concentration (Cmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood
Time frame: Pre-dose and at multiple timepoints up to Day 5
Time to Reach Maximum Observed Concentration (Tmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood
Time frame: Pre-dose and at multiple timepoints up to Day 5
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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
Time frame: Pre-dose and at multiple timepoints up to Day 5
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood
Time frame: Pre-dose and at multiple timepoints up to Day 5
Terminal Half-Life (t1/2) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood
Time frame: Pre-dose and at multiple timepoints up to Day 5
Apparent Clearance (CL/F) of BIIB091 in Plasma
Time frame: Pre-dose and at multiple timepoints up to Day 5
Apparent Volume of Distribution (Vz/F) of BIIB091 in Plasma
Time frame: Pre-dose and at multiple timepoints up to Day 5
Quantitative Profile of [14C]-BIIB091 Metabolites in Plasma
Time frame: Pre-dose and at multiple timepoints up to Day 4
Quantitative Profile of [14C]-BIIB091 Metabolites in Urine
Time frame: Pre-dose and at multiple timepoints up to Day 10
Quantitative Profile of [14C]-BIIB091 Metabolites in Feces
Time frame: Pre-dose and at multiple timepoints up to Day 10
Cmax of Plasma Metabolite 23 (M23)
Time frame: Pre-dose and at multiple timepoints up to Day 5
Tmax of Plasma M23
Time frame: Pre-dose and at multiple timepoints up to Day 5
AUClast of Plasma M23
Time frame: Pre-dose and at multiple timepoints up to Day 5
AUCinf of Plasma M23
Time frame: Pre-dose and at multiple timepoints up to Day 5
t1/2 of Plasma M23
Time frame: Pre-dose and at multiple timepoints up to Day 5
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From Day 1 up to end of study follow-up (Day 11)
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters
Time frame: From Day 1 up to Day 10
Number of Participants With Clinically Significant Vital Sign Abnormalities
Time frame: From Day 1 up to Day 10
Number of Participants With Clinically Significant Physical Examination Abnormalities
Time frame: From Day 1 up to Day 10
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities as Assessed by 12-Lead ECG Measurements
Time frame: From Day 1 up to Day 5
Number of Participants With Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Time frame: From Day 1 up to Day 11