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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 - Trial NCT06311786

Access comprehensive clinical trial information for NCT06311786 through Pure Global AI's free database. This Phase 1 trial is sponsored by Biogen and is currently Recruitment Completed. The study focuses on Healthy Volunteer. Target enrollment is 8 participants.

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NCT06311786
Phase 1
Recruitment Completed
drug
Trial Details
ClinicalTrials.gov • NCT06311786
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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, Open-Label Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of Single Oral Dose [14C]-BIIB091 in Healthy Male Participants

Study Focus

Healthy Volunteer

[14C]-BIIB091

Interventional

drug

Sponsor & Location

Biogen

Austin, United States of America

Timeline & Enrollment

Phase 1

Apr 08, 2024

May 13, 2024

8 participants

Primary Outcome

Amount of BIIB091 Excreted per Sampling Interval in Urine (Aeu),Amount of BIIB091 Excreted per Sampling Interval in Feces (Aef),Cumulative Amount of BIIB091 Excreted per Sampling Interval in Urine (Cum Aeu),Cumulative Amount of BIIB091 Excreted per Sampling Interval in Feces (Cum Aef),Percentage of BIIB091 Excreted per Sampling Interval in Urine (%Feu),Percentage of BIIB091 Excreted per Sampling Interval in Feces (%Fef),Cumulative Percentage of BIIB091 Excreted in Urine (Cum %Feu),Cumulative Percentage of BIIB091 Excreted in Feces (Cum %Fef),Maximum Observed Concentration (Cmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood,Time to Reach Maximum Observed Concentration (Tmax) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood,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,Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood,Terminal Half-Life (t1/2) of [14C]-BIIB091-Derived Materials in Plasma and Whole Blood,Apparent Clearance (CL/F) of BIIB091 in Plasma,Apparent Volume of Distribution (Vz/F) of BIIB091 in Plasma,Quantitative Profile of [14C]-BIIB091 Metabolites in Plasma,Quantitative Profile of [14C]-BIIB091 Metabolites in Urine,Quantitative Profile of [14C]-BIIB091 Metabolites in Feces

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.

ICD-10 Classifications

Healthy person accompanying sick person
Routine general health check-up of armed forces
Persons encountering health services in other circumstances
Persons encountering health services in other circumstances
Person encountering health services in unspecified circumstances

Data Source

ClinicalTrials.gov

NCT06311786

Non-Device Trial