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

Healthy Volunteer Clinical Trial

— Mass Balance  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311786
• Other study ID #: 257HV107
• Status: Recruiting
• Phase: Phase 1
• Start date: April 8, 2024
• Est. completion date: May 13, 2024

Study information

• Verified date: April 2024
• Source: Biogen
• Contact: US Biogen Clinical Trial Center
• Phone: 866-633-4636
• Email: clinicaltrials[@]biogen.com
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8
• Est. completion date: May 13, 2024
• Est. primary completion date: May 13, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• [14C]-BIIB091
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
United States	PPD Clinical Research Unit	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu)		Pre-dose and at multiple timepoints up to Day 10
Primary	Amount of BIIB091 Excreted per Sampling Interval in Feces (Aef)		Pre-dose and at multiple timepoints up to Day 10
Primary	Cumulative Amount of BIIB091 Excreted per Sampling Interval in Urine (Cum Aeu)		Pre-dose and at multiple timepoints up to Day 10
Primary	Cumulative Amount of BIIB091 Excreted per Sampling Interval in Feces (Cum Aef)		Pre-dose and at multiple timepoints up to Day 10
Primary	Percentage of BIIB091 Excreted per Sampling Interval in Urine (%Feu)		Pre-dose and at multiple timepoints up to Day 10
Primary	Percentage of BIIB091 Excreted per Sampling Interval in Feces (%Fef)		Pre-dose and at multiple timepoints up to Day 10
Primary	Cumulative Percentage of BIIB091 Excreted in Urine (Cum %Feu)		Pre-dose and at multiple timepoints up to Day 10
Primary	Cumulative Percentage of BIIB091 Excreted in Feces (Cum %Fef)		Pre-dose and at multiple timepoints up to Day 10
Primary	Maximum Observed Concentration (Cmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood		Pre-dose and at multiple timepoints up to Day 5
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Apparent Clearance (CL/F) of BIIB091 in Plasma		Pre-dose and at multiple timepoints up to Day 5
Primary	Apparent Volume of Distribution (Vz/F) of BIIB091 in Plasma		Pre-dose and at multiple timepoints up to Day 5
Primary	Quantitative Profile of [14C]-BIIB091 Metabolites in Plasma		Pre-dose and at multiple timepoints up to Day 4
Primary	Quantitative Profile of [14C]-BIIB091 Metabolites in Urine		Pre-dose and at multiple timepoints up to Day 10
Primary	Quantitative Profile of [14C]-BIIB091 Metabolites in Feces		Pre-dose and at multiple timepoints up to Day 10
Secondary	Cmax of Plasma Metabolite 23 (M23)		Pre-dose and at multiple timepoints up to Day 5
Secondary	Tmax of Plasma M23		Pre-dose and at multiple timepoints up to Day 5
Secondary	AUClast of Plasma M23		Pre-dose and at multiple timepoints up to Day 5
Secondary	AUCinf of Plasma M23		Pre-dose and at multiple timepoints up to Day 5
Secondary	t1/2 of Plasma M23		Pre-dose and at multiple timepoints up to Day 5
Secondary	Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)		From Day 1 up to end of study follow-up (Day 11)
Secondary	Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters		From Day 1 up to Day 10
Secondary	Number of Participants With Clinically Significant Vital Sign Abnormalities		From Day 1 up to Day 10
Secondary	Number of Participants With Clinically Significant Physical Examination Abnormalities		From Day 1 up to Day 10
Secondary	Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities as Assessed by 12-Lead ECG Measurements		From Day 1 up to Day 5
Secondary	Number of Participants With Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score		From Day 1 up to Day 11