Clinical trial NCT05152485: A Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants
Official title: A Phase 1, Randomized, Open-Label, Parallel-Arm Study to Evaluate the Relative Bioavailability of Two Formulations of BIIB104 and Assess the Effect of Food on the Pharmacokinetics of BIIB104 Following Administration of a Single, Fixed, Oral Dose of BIIB104 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2021-12-09
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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/Exclusion criteria may apply.

Primary outcomes:
measure: Area Under the Plasma Concentration-Time Curve from Time Zero to Time of the Last Measurable Concentration (AUClast) of BIIB104
timeFrame: Up to Day 6
measure: Area Under the Plasma Concentration-Time Curve from Time Zero to Infinity (AUCinf) of BIIB104
timeFrame: Up to Day 6
measure: Maximum Observed Plasma Concentration (Cmax) of BIIB104
timeFrame: Up to Day 6
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) for BIIB104
timeFrame: Up to Day 6
Secondary outcomes:
measure: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: From Day 1 up to end of study (up to Day 16)
measure: Number of Participants with Clinically Significant Abnormalities in Clinical Laboratory Parameters
timeFrame: From Day 1 up to end of study (up to Day 16)
measure: Number of Participants with Clinically Significant Abnormalities in Vital Signs
timeFrame: From Day 1 up to end of study (up to Day 16)
measure: Number of Participants with Clinically Significant Abnormalities in Physical Examination Parameters
timeFrame: From Day 1 up to end of study (up to Day 16)
Other outcomes:
Locations:
city: Miami
country: United States
facility: QPS MRA
state: Florida
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: