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 (Mass Balance)

A Phase 1, Open-Label Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of Single Oral Dose [14C]-BIIB091 in Healthy Male Participants

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 Overview

• Status: Not yet recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: [14C]-BIIB091

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: US Biogen Clinical Trial Center; Phone Number: 866-633-4636; Email: clinicaltrials@biogen.com
• Study Contact Backup: Name: Global Biogen Clinical Trial Center; Email: clinicaltrials@biogen.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Key Inclusion Criteria:

• Have a body mass index (BMI) of 18 to 32 kilograms per meter square (kg/m^2) and a total body weight greater than (>) 50 kg, as measured at Screening.
• History of regular bowel movements (averaging 1 or more bowel movements per day).
• Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Day -1.

Key Exclusion Criteria:

• History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease or other major disease, as determined by the Investigator.
• Participants enrolled in a previous radionucleotide study within 12 months prior to screening or who have received radiotherapy within 12 months prior to screening or such that total radioactivity would exceed acceptable dosimetry.
• Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the Investigator, within 90 days prior to Screening or between Screening and Day -1.
• Current enrollment in any other drug, biological, device, or clinical study or treatment with an investigational drug or approved therapy for investigational use within 30 days prior to Day -1 (24 weeks for biologics), or 5 half-lives, whichever is longer.
• Prior exposure to BIIB091 or any lymphocyte-depleting therapy or exposure to any lymphocyte-targeting therapy within 3 months prior to Day -1.

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-BIIB091; Participants will receive a single oral dose of [14C]-BIIB091 on Day 1.	Drug: [14C]-BIIB091; Administered as specified in the treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu)	Pre-dose and at multiple timepoints up to Day 10
Amount of BIIB091 Excreted per Sampling Interval in Feces (Aef)	Pre-dose and at multiple timepoints up to Day 10
Cumulative Amount of BIIB091 Excreted per Sampling Interval in Urine (Cum Aeu)	Pre-dose and at multiple timepoints up to Day 10
Cumulative Amount of BIIB091 Excreted per Sampling Interval in Feces (Cum Aef)	Pre-dose and at multiple timepoints up to Day 10
Percentage of BIIB091 Excreted per Sampling Interval in Urine (%Feu)	Pre-dose and at multiple timepoints up to Day 10
Percentage of BIIB091 Excreted per Sampling Interval in Feces (%Fef)	Pre-dose and at multiple timepoints up to Day 10
Cumulative Percentage of BIIB091 Excreted in Urine (Cum %Feu)	Pre-dose and at multiple timepoints up to Day 10
Cumulative Percentage of BIIB091 Excreted in Feces (Cum %Fef)	Pre-dose and at multiple timepoints up to Day 10
Maximum Observed Concentration (Cmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood	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	Pre-dose and at multiple timepoints up to Day 5
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	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	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	Pre-dose and at multiple timepoints up to Day 5
Apparent Clearance (CL/F) of BIIB091 in Plasma	Pre-dose and at multiple timepoints up to Day 5
Apparent Volume of Distribution (Vz/F) of BIIB091 in Plasma	Pre-dose and at multiple timepoints up to Day 5
Quantitative Profile of [14C]-BIIB091 Metabolites in Plasma	Pre-dose and at multiple timepoints up to Day 4
Quantitative Profile of [14C]-BIIB091 Metabolites in Urine	Pre-dose and at multiple timepoints up to Day 10
Quantitative Profile of [14C]-BIIB091 Metabolites in Feces	Pre-dose and at multiple timepoints up to Day 10

Secondary Outcome Measures

Outcome Measure	Time Frame
Cmax of Plasma Metabolite 23 (M23)	Pre-dose and at multiple timepoints up to Day 5
Tmax of Plasma M23	Pre-dose and at multiple timepoints up to Day 5
AUClast of Plasma M23	Pre-dose and at multiple timepoints up to Day 5
AUCinf of Plasma M23	Pre-dose and at multiple timepoints up to Day 5
t1/2 of Plasma M23	Pre-dose and at multiple timepoints up to Day 5
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	From Day 1 up to end of study follow-up (Day 11)
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters	From Day 1 up to Day 10
Number of Participants With Clinically Significant Vital Sign Abnormalities	From Day 1 up to Day 10
Number of Participants With Clinically Significant Physical Examination Abnormalities	From Day 1 up to Day 10
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities as Assessed by 12-Lead ECG Measurements	From Day 1 up to Day 5
Number of Participants With Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score	From Day 1 up to Day 11

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Director: Medical Director, Biogen

Study record dates

Study Major Dates

• Study Start (Estimated): April 9, 2024
• Primary Completion (Estimated): May 13, 2024
• Study Completion (Estimated): May 13, 2024

Study Registration Dates

• First Submitted: March 8, 2024
• First Submitted That Met QC Criteria: March 8, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 257HV107

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No