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[14C]-BIIB091 for Healthy Subjects (Mass Balance Trial)

Phase 1
Waitlist Available
Research Sponsored by Biogen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have a body mass index (BMI) of 18 to 32 kg/m^2 and a total body weight > 50 kg, as measured at Screening
Be between 18 and 65 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from day 1 up to day 11
Awards & highlights

Summary

This trial aims to understand how a drug called BIIB091 is absorbed and processed by the body in healthy men. It will also investigate the safety of BIIB091 and how its byproducts are ex

Who is the study for?
This trial is for healthy male participants who have a BMI of 18 to 32 kg/m^2, weigh over 50 kg, and typically have at least one bowel movement per day. They must test negative for COVID-19 right before the study starts.Check my eligibility
What is being tested?
[14C]-BIIB091's journey through the body is being studied. Researchers want to see where it goes, how it's broken down, and its levels in blood, urine, and stool after a single oral dose in healthy men.See study design
What are the potential side effects?
While specific side effects are not listed here, the safety of BIIB091 will be monitored throughout the study as researchers look for any adverse reactions in participants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My BMI is between 18 and 32, and I weigh more than 50 kg.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any major health issues as decided by my doctor.
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I haven't been in a radionuclide study or had radiotherapy in the last year.
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I haven't had a serious infection like pneumonia in the last 3 months.
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I have not taken BIIB091 or any lymphocyte-depleting drugs recently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from day 1 up to day 11
This trial's timeline: 3 weeks for screening, Varies for treatment, and from day 1 up to day 11 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Amount of BIIB091 Excreted per Sampling Interval in Feces (Aef)
Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu)
Apparent Clearance (CL/F) of BIIB091 in Plasma
+15 more
Secondary outcome measures
AUCinf of Plasma M23
AUClast of Plasma M23
Cmax of Plasma Metabolite 23 (M23)
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: [14C]-BIIB091Experimental Treatment1 Intervention
Participants will receive a single oral dose of [14C]-BIIB091 on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
[14C]-BIIB091
2024
Completed Phase 1
~10

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

BiogenLead Sponsor
640 Previous Clinical Trials
467,113 Total Patients Enrolled
Medical DirectorStudy DirectorBiogen
2,801 Previous Clinical Trials
8,070,322 Total Patients Enrolled
~5 spots leftby Jul 2025