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The primary objectives of this study are to evaluate the relative bioavailability of the BIIB104 test formulation compared with the reference formulation in healthy Caucasian male adult participants in the fasted state and to assess the impact of food on BIIB104 pharmacokinetic (PK) parameters for the test formulation in healthy Caucasian male adult participants.
The secondary objective of the study is to assess the safety and tolerability of BIIB104 0.5 milligrams (mg) test formulation in the fasted and fed states following single-dose administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BIIB104 0.5 mg Reference Formulation (Fasted State) | Active Comparator | Participants will receive BIIB104 0.5 mg, immediate-release liquid-filled hard-shell capsule, orally, on Day 1 in the fasted state. |
|
| BIIB104 0.5 mg Test Formulation (Fasted State) | Experimental | Participants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fasted state. |
|
| BIIB104 0.5 mg Test Formulation (Fed State) | Experimental | Participants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fed state. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BIIB104 Reference Formulation | Drug | Administered as specified in the treatment arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve from Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB104 | Up to Day 6 | |
| Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUCinf) of BIIB104 | Up to Day 6 | |
| Maximum Observed Plasma Concentration (Cmax) of BIIB104 | Up to Day 6 | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for BIIB104 | Up to Day 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. TEAEs are AEs that start or worsen after receiving the study drug. An SAE is any untoward medical occurrence that at any dose results in death; in the view of the investigator, places the participant at immediate risk of death (a life-threatening event); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect or is a medically important event. |
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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 |
|---|---|---|---|---|---|---|
| QPS MRA | Miami | Florida | 33143 | United States |
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| BIIB104 Test Formulation | Drug | Administered as specified in the treatment arm |
|
| From Day 1 up to end of study (up to Day 16) |
| Number of Participants with Clinically Significant Abnormalities in Clinical Laboratory Parameters | From Day 1 up to end of study (up to Day 16) |
| Number of Participants with Clinically Significant Abnormalities in Vital Signs | From Day 1 up to end of study (up to Day 16) |
| Number of Participants with Clinically Significant Abnormalities in Physical Examination Parameters | From Day 1 up to end of study (up to Day 16) |