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Completed

NCT Number: 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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

PPD Clinical Research Unit

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[14C]-BIIB091

Drug

Administered as specified in the treatment arm.

Primary outcomes

  1. Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu)

    Time frame: Pre-dose and at multiple timepoints up to Day 10

  2. Amount of BIIB091 Excreted per Sampling Interval in Feces (Aef)

    Time frame: Pre-dose and at multiple timepoints up to Day 10

  3. Cumulative Amount of BIIB091 Excreted per Sampling Interval in Urine (Cum Aeu)

    Time frame: Pre-dose and at multiple timepoints up to Day 10

  4. Cumulative Amount of BIIB091 Excreted per Sampling Interval in Feces (Cum Aef)

    Time frame: Pre-dose and at multiple timepoints up to Day 10

  5. Percentage of BIIB091 Excreted per Sampling Interval in Urine (%Feu)

    Time frame: Pre-dose and at multiple timepoints up to Day 10

  6. Percentage of BIIB091 Excreted per Sampling Interval in Feces (%Fef)

    Time frame: Pre-dose and at multiple timepoints up to Day 10

  7. Cumulative Percentage of BIIB091 Excreted in Urine (Cum %Feu)

    Time frame: Pre-dose and at multiple timepoints up to Day 10

  8. Cumulative Percentage of BIIB091 Excreted in Feces (Cum %Fef)

    Time frame: Pre-dose and at multiple timepoints up to Day 10

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. Apparent Clearance (CL/F) of BIIB091 in Plasma

    Time frame: Pre-dose and at multiple timepoints up to Day 5

  15. Apparent Volume of Distribution (Vz/F) of BIIB091 in Plasma

    Time frame: Pre-dose and at multiple timepoints up to Day 5

  16. Quantitative Profile of [14C]-BIIB091 Metabolites in Plasma

    Time frame: Pre-dose and at multiple timepoints up to Day 4

  17. Quantitative Profile of [14C]-BIIB091 Metabolites in Urine

    Time frame: Pre-dose and at multiple timepoints up to Day 10

  18. Quantitative Profile of [14C]-BIIB091 Metabolites in Feces

    Time frame: Pre-dose and at multiple timepoints up to Day 10

Secondary outcomes

  1. Cmax of Plasma Metabolite 23 (M23)

    Time frame: Pre-dose and at multiple timepoints up to Day 5

  2. Tmax of Plasma M23

    Time frame: Pre-dose and at multiple timepoints up to Day 5

  3. AUClast of Plasma M23

    Time frame: Pre-dose and at multiple timepoints up to Day 5

  4. AUCinf of Plasma M23

    Time frame: Pre-dose and at multiple timepoints up to Day 5

  5. t1/2 of Plasma M23

    Time frame: Pre-dose and at multiple timepoints up to Day 5

  6. 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)

  7. Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters

    Time frame: From Day 1 up to Day 10

  8. Number of Participants With Clinically Significant Vital Sign Abnormalities

    Time frame: From Day 1 up to Day 10

  9. Number of Participants With Clinically Significant Physical Examination Abnormalities

    Time frame: From Day 1 up to Day 10

  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

  11. Number of Participants With Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score

    Time frame: From Day 1 up to Day 11

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Acronym: Mass Balance

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
May 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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