Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGBIIB104 Reference Formulation
Administered as specified in the treatment arm
DRUGBIIB104 Test Formulation
Administered as specified in the treatment arm
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Has a body mass index (BMI) between 18 and 30 kilogram per square meter (kg/m\^2), inclusive and a total body weight \>50 kilograms \[110 pound (lb)\]. Key
Exclusion criteria
* Participates in other studies involving treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) prior to randomization and/or during study participation. * Previously participated in this study or previous studies with BIIB104. NOTE: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Reach Maximum Observed Plasma Concentration (Tmax) for BIIB104 | Up to Day 6 |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | From Day 1 up to end of study (up to Day 16) | 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. |
| 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) | — |
Countries
United States
Outcome results
None listed