BIIB091 Processing in Healthy Participants

No longer recruiting at 1 trial location

Overseen By Global Biogen Clinical Trial Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Biogen

Disqualifiers: Cardiac, Endocrine, GI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 25 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand how the body processes different tablet forms of a new treatment called BIIB091, both with and without food. The study compares two new types: "extended-release" (ER) tablets, which release the drug slowly, and "gastro-retentive" (GR) tablets, which remain in the stomach longer. Researchers aim to determine how these new forms perform compared to the immediate-release (IR) tablets, particularly when food is involved. Individuals who are generally healthy and do not have significant dietary changes or major health issues might be suitable for this study. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that BIIB091 is under study to assess its safety and efficacy, particularly for treating conditions like multiple sclerosis. Studies have found that BIIB091 targets specific cells in the body to help manage inflammation. This targeting is promising because the drug is designed to work precisely where needed, potentially reducing unwanted side effects.

Although BIIB091 remains in early human testing, earlier studies have not reported any serious side effects. This suggests the drug might be well-tolerated, but further research is necessary to confirm its safety. Researchers are also testing BIIB091 in different forms, such as extended-release and gastro-retentive tablets, which might have varying safety profiles. These forms help control the drug's release in the body, potentially minimizing side effects.

Overall, while BIIB091 shows potential, the current study phase primarily focuses on understanding how the body processes it. Safety data is still being collected, and more detailed results will emerge from future studies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about BIIB091 because it offers multiple formulations that could provide flexible dosing options for patients. Unlike existing treatments that might have a single release profile, BIIB091 includes immediate release (IR), gastro-retentive slow (GR-slow), gastro-retentive fast (GR-fast), extended release slow (ER-slow), and extended release fast (ER-fast) options. This variety could allow for more personalized treatment plans, potentially improving patient adherence and convenience. Additionally, the extended release versions may help maintain consistent drug levels in the body, which could enhance effectiveness and reduce side effects.

What evidence suggests that this trial's treatments could be effective?

Research shows that BIIB091 targets B-cell activation, a key component of the immune system. Studies have found that BIIB091 can block B-cell activation in healthy individuals, suggesting it might help control immune activity. This could benefit conditions characterized by an overactive immune system. In this trial, participants will receive different versions of BIIB091, including extended-release (ER) and gastro-retentive (GR), which the body absorbs differently. These versions aim to maintain steady drug levels, potentially enhancing effectiveness. ^{1 3 6 7 8}

Who Is on the Research Team?

Medical Director

Principal Investigator

Biogen

Are You a Good Fit for This Trial?

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

For Japanese participants: Have biological parents and grandparents of Japanese origin. If living outside of Japan for more than 5 years, must not have significantly modified diet since leaving Japan.

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

Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at Check-in (Day -1)

Exclusion Criteria

History of torsades de pointes or additional risk factors for torsades de pointes

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

Treatment

Participants receive single doses of different BIIB091 formulations in a 6-period crossover design, with 3 days of no dosing between each period

25 days

Continuous stay at research center

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• BIIB091

Trial Overview 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.

How Is the Trial Designed?

Group I: BIIB091 IR Experimental Treatment 1 Intervention

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

Group II: BIIB091 GR-slow Experimental Treatment 1 Intervention

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

Group III: BIIB091 GR-fast Experimental Treatment 1 Intervention

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

Group IV: BIIB091 ER-slow Fasted Experimental Treatment 1 Intervention

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

Group V: BIIB091 ER-slow Experimental Treatment 1 Intervention

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

Group VI: BIIB091 ER-fast Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06640933

A Study to Find Out How Different Forms of BIIB091 is ... The primary objective of this study is to characterize the pharmacokinetics (PK) of BIIB091 after a single oral dose of different BIIB091 formulations with or ...

2. withpower.com withpower.com/trial/biib091-processing-in-healthy-participants-85cab

BIIB091 Processing in Healthy Participants 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.

3. trial.medpath.com trial.medpath.com/clinical-trial/192e694fd63715a2/nct06640933-pharmacokinetics-biib091-formulations-food-effect

A Study to Find Out How Different Forms of BIIB091 ... - MedPath The primary objective of this study is to characterize the pharmacokinetics (PK) of BIIB091 after a single oral dose of different BIIB091 formulations with or ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04564612

Study of BIIB091 Formulations in Healthy Participants Participants will receive single oral dose of BIIB091 on Day 1 of each study period, in fasted state, for up to 5 periods. There will be a minimum 7-day washout ...

5. meddatax.com meddatax.com/clinical-trials/NCT06640933

A Study to Find Out How Different Forms of BIIB091 is ... In this study, researchers will learn how the body processes new tablet forms of BIIB091 when taken with and without food.

6. clinicaltrials.eu clinicaltrials.eu/inn/biib091/

BIIB091: A Promising New Drug for Multiple Sclerosis ... BIIB091 is an investigational drug being studied for its potential in treating multiple sclerosis (MS). Clinical trials are underway to evaluate its safety, how ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8204096/

Next‐generation Bruton's tyrosine kinase inhibitor BIIB091 ... Bruton's tyrosine kinase inhibitor BIIB091 selectively and potently inhibits B cell and Fc receptor signaling and downstream functions in B cells and myeloid ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05798520

NCT05798520 | A Study to Learn About the Safety of ... In this study, researchers will learn more about a study drug called BIIB091 in participants with MS who may be experiencing relapses. It is a 2-part study.