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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: BIIB104 Test Formulation; Drug: BIIB104 Reference Formulation

• Registration Number: NCT05152485
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-08
• Study First Submitted QC: 2021-12-08
• Study First Posted: 2021-12-09
• Study Start: 2021-12-15
• Primary Completion: 2022-01-31
• Study Completion: 2022-01-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BIIB104 0.5 mg Test Formulation (Fasted State)	BIIB104 Test Formulation	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)	BIIB104 Test Formulation	Participants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fed state.
BIIB104 0.5 mg Reference Formulation (Fasted State)	BIIB104 Reference Formulation	Participants will receive BIIB104 0.5 mg, immediate-release liquid-filled hard-shell capsule, orally, on Day 1 in the fasted state.

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

QPS MRA; 🇺🇸 Miami, Florida, United States