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

NCT05152485 | Completed Phase 1 FDA Drug

• 1 other identifier: 263HV109
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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)

• 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)

Study Arms (3)

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.

Drug: BIIB104 Reference Formulation

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.

Drug: BIIB104 Test Formulation

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.

Drug: BIIB104 Test Formulation

Interventions

BIIB104 Reference Formulation DRUG

Administered as specified in the treatment arm

BIIB104 0.5 mg Reference Formulation (Fasted State)

BIIB104 Test Formulation DRUG

Administered as specified in the treatment arm

BIIB104 0.5 mg Test Formulation (Fasted State); BIIB104 0.5 mg Test Formulation (Fed State)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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 \[110 pound (lb)\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

QPS MRA

Miami, Florida, 33143, United States

Location

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 9, 2021
• Study Start: December 15, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)