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)

May 22, 2024 updated by: Biogen

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Texas
      • Austin, Texas, United States, 78744
        • PPD Clinical Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu)
Time Frame: Pre-dose and at multiple timepoints up to Day 10
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
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
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
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
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
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
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
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
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
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
Time Frame: Pre-dose and at multiple timepoints up to Day 5
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
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
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
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
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
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
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
Pre-dose and at multiple timepoints up to Day 10

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Cmax of Plasma Metabolite 23 (M23)
Time Frame: Pre-dose and at multiple timepoints up to Day 5
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
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
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
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
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)
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
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
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
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
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
From Day 1 up to Day 11

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Biogen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 8, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 11, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 11, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 15, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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