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

NCT06311786 | Completed Phase 1 FDA Drug

• 1 other identifier: 257HV107
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (18)

• 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 Outcomes (11)

• 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

Study Arms (1)

[14C]-BIIB091

EXPERIMENTAL

Participants will receive a single oral dose of \[14C\]-BIIB091 on Day 1.

Drug: [14C]-BIIB091

Interventions

[14C]-BIIB091 DRUG

Administered as specified in the treatment arm.

[14C]-BIIB091

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

PPD Clinical Research Unit

Austin, Texas, 78744, United States

Location

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: April 8, 2024
• Primary Completion: May 11, 2024
• Study Completion: May 11, 2024
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)