Healthy VolunteerPhase 1Mass BalanceNCT06311786
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
A Phase 1 study testing [14C]-BIIB091 in people with Healthy Volunteer, run by Biogen at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- [14C]-BIIB091
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to 11 May 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Volunteer
- Being tested
- [14C]-BIIB091
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[14C]-BIIB091Drug
Administered as specified in the treatment arm.
| Study group | Role | What they receive |
|---|---|---|
| [14C]-BIIB091 | Experimental | Participants will receive a single oral dose of [14C]-BIIB091 on Day 1. Receives: Drug: [14C]-BIIB091 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu)
Measured: Pre-dose and at multiple timepoints up to Day 10
Amount of BIIB091 Excreted per Sampling Interval in Feces (Aef)
Measured: Pre-dose and at multiple timepoints up to Day 10
Cumulative Amount of BIIB091 Excreted per Sampling Interval in Urine (Cum Aeu)
Measured: Pre-dose and at multiple timepoints up to Day 10
Cumulative Amount of BIIB091 Excreted per Sampling Interval in Feces (Cum Aef)
Measured: Pre-dose and at multiple timepoints up to Day 10
Percentage of BIIB091 Excreted per Sampling Interval in Urine (%Feu)
Measured: Pre-dose and at multiple timepoints up to Day 10
Percentage of BIIB091 Excreted per Sampling Interval in Feces (%Fef)
Measured: Pre-dose and at multiple timepoints up to Day 10
Cumulative Percentage of BIIB091 Excreted in Urine (Cum %Feu)
Measured: Pre-dose and at multiple timepoints up to Day 10
Cumulative Percentage of BIIB091 Excreted in Feces (Cum %Fef)
Measured: Pre-dose and at multiple timepoints up to Day 10
Maximum Observed Concentration (Cmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Pre-dose and at multiple timepoints up to Day 5
Apparent Clearance (CL/F) of BIIB091 in Plasma
Measured: Pre-dose and at multiple timepoints up to Day 5
Apparent Volume of Distribution (Vz/F) of BIIB091 in Plasma
Measured: Pre-dose and at multiple timepoints up to Day 5
Quantitative Profile of [14C]-BIIB091 Metabolites in Plasma
Measured: Pre-dose and at multiple timepoints up to Day 4
Quantitative Profile of [14C]-BIIB091 Metabolites in Urine
Measured: Pre-dose and at multiple timepoints up to Day 10
Quantitative Profile of [14C]-BIIB091 Metabolites in Feces
Measured: Pre-dose and at multiple timepoints up to Day 10
Secondary outcomes (11)
Cmax of Plasma Metabolite 23 (M23)
Measured: Pre-dose and at multiple timepoints up to Day 5
Tmax of Plasma M23
Measured: Pre-dose and at multiple timepoints up to Day 5
AUClast of Plasma M23
Measured: Pre-dose and at multiple timepoints up to Day 5
AUCinf of Plasma M23
Measured: Pre-dose and at multiple timepoints up to Day 5
t1/2 of Plasma M23
Measured: Pre-dose and at multiple timepoints up to Day 5
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: From Day 1 up to end of study follow-up (Day 11)
Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters
Measured: From Day 1 up to Day 10
Number of Participants With Clinically Significant Vital Sign Abnormalities
Measured: From Day 1 up to Day 10
Number of Participants With Clinically Significant Physical Examination Abnormalities
Measured: From Day 1 up to Day 10
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities as Assessed by 12-Lead ECG Measurements
Measured: From Day 1 up to Day 5
Number of Participants With Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Measured: From Day 1 up to Day 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start8 Apr 2024
- Primary completion11 May 2024
- Study completion11 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06311786
- Sponsor's protocol ID
- 257HV107
- Acronym
- Mass Balance
- Status last verified
- May 2024
- First submitted
- 8 Mar 2024
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of Single Oral Dose [14C]-BIIB091 in Healthy Male Participants
- ClinicalTrials.gov ID
- NCT06311786
- Acronym / sponsor ID
- Mass Balance / 257HV107
- Conditions
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- 11 May 2024 (actual)
- Study completion
- 11 May 2024 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [14C]-BIIB091 | Experimental | Drug: [14C]-BIIB091Participants will receive a single oral dose of [14C]-BIIB091 on Day 1. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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 (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [14C]-BIIB091Administered as specified in the treatment arm. | Drug | [14C]-BIIB091 |
Primary outcome
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
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
11 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Individual participant dataSharing planned: Yes. In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [14C]-BIIB091 in people with Healthy Volunteer, run by Biogen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu) (time frame: Pre-dose and at multiple timepoints up to Day 10). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.