Clinical trial NCT06311786: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. The study will also help researchers learn more about the safety of BIIB091 in healthy male participants.


Eligibility criteria: 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.

Primary outcomes:
measure: Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu)
timeFrame: Pre-dose and at multiple timepoints up to Day 10
measure: Amount of BIIB091 Excreted per Sampling Interval in Feces (Aef)
timeFrame: Pre-dose and at multiple timepoints up to Day 10
measure: Cumulative Amount of BIIB091 Excreted per Sampling Interval in Urine (Cum Aeu)
timeFrame: Pre-dose and at multiple timepoints up to Day 10
measure: Cumulative Amount of BIIB091 Excreted per Sampling Interval in Feces (Cum Aef)
timeFrame: Pre-dose and at multiple timepoints up to Day 10
measure: Percentage of BIIB091 Excreted per Sampling Interval in Urine (%Feu)
timeFrame: Pre-dose and at multiple timepoints up to Day 10
measure: Percentage of BIIB091 Excreted per Sampling Interval in Feces (%Fef)
timeFrame: Pre-dose and at multiple timepoints up to Day 10
measure: Cumulative Percentage of BIIB091 Excreted in Urine (Cum %Feu)
timeFrame: Pre-dose and at multiple timepoints up to Day 10
measure: Cumulative Percentage of BIIB091 Excreted in Feces (Cum %Fef)
timeFrame: Pre-dose and at multiple timepoints up to Day 10
measure: Maximum Observed Concentration (Cmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood
timeFrame: Pre-dose and at multiple timepoints up to Day 5
measure: Time to Reach Maximum Observed Concentration (Tmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood
timeFrame: Pre-dose and at multiple timepoints up to Day 5
measure: 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
timeFrame: Pre-dose and at multiple timepoints up to Day 5
measure: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood
timeFrame: Pre-dose and at multiple timepoints up to Day 5
measure: Terminal Half-Life (t1/2) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood
timeFrame: Pre-dose and at multiple timepoints up to Day 5
measure: Apparent Clearance (CL/F) of BIIB091 in Plasma
timeFrame: Pre-dose and at multiple timepoints up to Day 5
measure: Apparent Volume of Distribution (Vz/F) of BIIB091 in Plasma
timeFrame: Pre-dose and at multiple timepoints up to Day 5
measure: Quantitative Profile of [14C]-BIIB091 Metabolites in Plasma
timeFrame: Pre-dose and at multiple timepoints up to Day 4
measure: Quantitative Profile of [14C]-BIIB091 Metabolites in Urine
timeFrame: Pre-dose and at multiple timepoints up to Day 10
measure: Quantitative Profile of [14C]-BIIB091 Metabolites in Feces
timeFrame: Pre-dose and at multiple timepoints up to Day 10
Secondary outcomes:
measure: Cmax of Plasma Metabolite 23 (M23)
timeFrame: Pre-dose and at multiple timepoints up to Day 5
measure: Tmax of Plasma M23
timeFrame: Pre-dose and at multiple timepoints up to Day 5
measure: AUClast of Plasma M23
timeFrame: Pre-dose and at multiple timepoints up to Day 5
measure: AUCinf of Plasma M23
timeFrame: Pre-dose and at multiple timepoints up to Day 5
measure: t1/2 of Plasma M23
timeFrame: Pre-dose and at multiple timepoints up to Day 5
measure: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to end of study follow-up (Day 11)
measure: Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters
timeFrame: From Day 1 up to Day 10
measure: Number of Participants With Clinically Significant Vital Sign Abnormalities
timeFrame: From Day 1 up to Day 10
measure: Number of Participants With Clinically Significant Physical Examination Abnormalities
timeFrame: From Day 1 up to Day 10
measure: Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities as Assessed by 12-Lead ECG Measurements
timeFrame: From Day 1 up to Day 5
measure: Number of Participants With Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
timeFrame: From Day 1 up to Day 11
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Clinical Research Unit
state: Texas
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: