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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

NCT ID: NCT05152485

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-15

Study Completion Date

2022-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BIIB104 0.5 mg Reference Formulation (Fasted State)

Participants will receive BIIB104 0.5 mg, immediate-release liquid-filled hard-shell capsule, orally, on Day 1 in the fasted state.

Group Type ACTIVE_COMPARATOR

BIIB104 Reference Formulation

Intervention Type DRUG

Administered as specified in the treatment arm

BIIB104 0.5 mg Test Formulation (Fasted State)

Participants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fasted state.

Group Type EXPERIMENTAL

BIIB104 Test Formulation

Intervention Type DRUG

Administered as specified in the treatment arm

BIIB104 0.5 mg Test Formulation (Fed State)

Participants will receive BIIB104 0.5 mg, immediate-release softgel capsule, orally, on Day 1 in the fed state.

Group Type EXPERIMENTAL

BIIB104 Test Formulation

Intervention Type DRUG

Administered as specified in the treatment arm

Interventions

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BIIB104 Reference Formulation

Administered as specified in the treatment arm

Intervention Type DRUG

BIIB104 Test Formulation

Administered as specified in the treatment arm

Intervention Type DRUG

Eligibility Criteria

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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 \[110 pound (lb)\].

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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QPS MRA

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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263HV109

Identifier Type: -

Identifier Source: org_study_id

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