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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-BIIB091 | Experimental | Participants will receive a single oral dose of [14C]-BIIB091 on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-BIIB091 | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PPD Clinical Research Unit | Austin | Texas | 78744 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| 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 |
| 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 |
| Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Day 1 up to end of study follow-up (Day 11) |
| Number of Participants With Clinically Significant Abnormalities in Clinical Laboratory Parameters | From Day 1 up to Day 10 |
| Number of Participants With Clinically Significant Vital Sign Abnormalities | From Day 1 up to Day 10 |
| Number of Participants With Clinically Significant Physical Examination Abnormalities | From Day 1 up to Day 10 |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities as Assessed by 12-Lead ECG Measurements | From Day 1 up to Day 5 |
| Number of Participants With Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score | From Day 1 up to Day 11 |