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A Study to Find Out How Different Forms of BIIB091 is Processed in The Body With and Without Food in Healthy Participants

NCT06640933 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-02-18

No results posted yet for this study

Summary

In this study, researchers will learn how the body processes new tablet forms of BIIB091 when taken with and without food. One new form of BIIB091 is an "extended release" tablet, also known as "ER." This form helps release BIIB091 slowly and consistently, helping to keep steady drug levels in the body for longer. The other new form is a "gastro-retentive" tablet, also known as "GR." This form has a special coating that swells and allows BIIB091 to stay in the stomach longer. For both GR and ER tablets, there are also "slow" and "fast" forms that change how quickly BIIB091 is released into the body. But, eating food with these tablets may affect how much BIIB091 is in the body.

The main objective of this study is to learn how 2 new forms of BIIB091, which are released into the body at different rates, are processed in the body. Researchers also want to learn how these new forms compare to the "immediate release" tablet, also known as "IR". This form delivers BIIB091 immediately into the body.

The main question researchers want to answer in this study is:

* How does the body process different tablet forms of BIIB091 with or without food?

Researchers will also learn more about:

* How the body processes the 2 new tablet forms of BIIB091 with food compared to the IR tablet form with food
* How the body processes the ER tablet form of BIIB091 with food compared to without food
* Any medical problems the participants have during the study
* Any changes in the participants' overall health during the study

This study will be done as follows:

* Participants will be screened to check if they can join the study. The screening period will be up to 22 days, after which eligible participants will check into their study research center.
* Participants will be randomly assigned to 1 of 6 groups. In each group, the participants will take the below tablet forms, but in different orders:

* Immediate-Release (IR)
* Gastro-Retentive slow (GR-slow)
* Gastro-Retentive fast (GR-fast)
* Extended-Release slow (ER-slow)
* Extended-Release fast (ER-fast)
* ER-slow, without food
* Each period includes the participant taking a single dose of what they were assigned to on the first day. There will be 3 days of no dosing in each period. The participant will then move to the next tablet form assigned. This will continue until each participant has taken a single dose of each of the 6 tablet forms.
* Participants will remain at their study research center for 25 days for the treatment periods. Afterwards, there will be follow-up visit 11 to 14 days after each participant's last dose. Each participant will be in the study for up to 57 days.

Conditions

  • Healthy Volunteer

Interventions

DRUG

BIIB091

Administered as specified in the treatment arm.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Biogen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-16
Primary Completion
2025-02-07
Completion
2025-02-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06640933 on ClinicalTrials.gov