BIIB091 Processing in Healthy Participants

Palo Alto (17 mi)

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Biogen

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for healthy individuals with Japanese ancestry, a BMI of 18-32 kg/m^2, and weight over 50 kg. They must test negative for COVID-19 before check-in and have not significantly changed their diet if they've lived outside Japan for more than 5 years.

Inclusion Criteria

My BMI is between 18 and 32, and I weigh more than 50 kg.

Exclusion Criteria

I do not have any major health issues as decided by my doctor.

I have not had a serious infection like pneumonia in the last 3 months.

Treatment Details

Researchers are testing how the body processes new tablet forms of BIIB091: extended release (ER) and gastro-retentive (GR), both in 'slow' and 'fast' versions. They're comparing these to an immediate release (IR) form, with or without food.

6Treatment groups

Experimental Treatment

Group I: BIIB091 IRExperimental Treatment1 Intervention

Participants will receive BIIB091 IR tablets on Day 1 of its respective period, with food.

Group II: BIIB091 GR-slowExperimental Treatment1 Intervention

Participants will receive BIIB091 GR-slow tablets on Day 1 of its respective period, with food.

Group III: BIIB091 GR-fastExperimental Treatment1 Intervention

Participants will receive BIIB091 GR-fast tablets on Day 1 of its respective period, with food.

Group IV: BIIB091 ER-slow FastedExperimental Treatment1 Intervention

Participants will receive BIIB091 ER-slow tablets on Day 1 of its respective period, without food.

Group V: BIIB091 ER-slowExperimental Treatment1 Intervention

Participants will receive BIIB091 ER-slow tablets on Day 1 of its respective period, with food.