BIIB091 for Heart Activity in Healthy Subjects

Overseen By Global Biogen Clinical Trial Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Biogen

Must not be taking: QT prolonging drugs

Disqualifiers: Cardiac disease, HIV, Hepatitis, others

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

Compensation: Varies

Number of Visits: 1

Duration: 15 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to observe changes in the heart's electrical activity when taking the drug BIIB091. Researchers focus on the QT interval, which measures the time the heart takes to recharge between beats, to determine if BIIB091 affects it. Participants will be divided into two groups: one will receive varying doses of BIIB091, and the other will take moxifloxacin, an antibiotic known to impact heart rhythms, for comparison. Ideal participants are healthy individuals without a history of significant heart or other major health issues. As a Phase 1 trial, the research seeks to understand 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 requires that you do not use any prescription or over-the-counter medications, including herbal supplements, that are known to prolong the QT/QTc interval or induce torsades de pointes. If you are taking such medications, you may need to stop them to participate in the study.

Is there any evidence suggesting that BIIB091 is likely to be safe for humans?

In previous studies, researchers found that BIIB091 can affect the heart's electrical signals, specifically altering the QT interval, which is the time for the heart to beat and reset. A longer QT interval can increase the risk of abnormal heartbeats.

So far, studies have examined how well healthy individuals tolerate BIIB091, focusing on its effects on the heart at various doses. Some reports indicate that BIIB091 can change heart activity, but researchers continue to study the frequency and severity of these changes.

Since BIIB091 is in the early testing stages, researchers are still learning about its safety. This phase is crucial for identifying any common or serious side effects and understanding how the body processes the drug. While there is interest in its potential benefits, ensuring its safety is essential before wider use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about BIIB091 because it represents a novel approach to evaluating heart activity in healthy subjects. Unlike traditional cardiac treatments that often involve invasive procedures or long-term medication regimens, BIIB091 offers a potentially less invasive alternative by being administered orally. This trial aims to uncover how BIIB091 interacts with heart activity, which could lead to new insights and advancements in cardiac health monitoring and treatment. By understanding its unique effects, researchers hope to pave the way for innovative strategies in heart care.

What evidence suggests that BIIB091 could be an effective treatment for heart activity?

Studies have shown that BIIB091 can affect the heart's electrical activity, specifically the QT interval, which measures the time for the heart to beat and then prepare to beat again. A longer QT interval can lead to irregular heartbeats. Previous findings suggest that BIIB091 can alter this interval, but further research is needed to fully understand its effects. In this trial, participants will receive either BIIB091 or a placebo to assess its impact on the QT interval in healthy individuals. ^{1 2 5 6 7}

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 a body mass index (BMI) between 18 and 32, weighing over 50 kg. They must be in good health as determined by medical history and screening evaluations, including a negative COVID-19 test at check-in.

Inclusion Criteria

I tested negative for COVID-19 recently.

I am in good health according to my doctor's evaluation.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 29 days

Treatment

Participants receive either BIIB091 or moxifloxacin, along with placebos, to assess the effect on cardiac repolarization

15 days

Inpatient stay at the study research center

Follow-up

Participants are monitored for safety and effectiveness after treatment

11 to 14 days

1 follow-up visit

What Are the Treatments Tested in This Trial?

Interventions

• BIIB091

Trial Overview The study tests how the heart's electrical activity responds to multiple doses of BIIB091 over five days. It compares low and high doses of BIIB091 against moxifloxacin, an antibiotic known to affect heart rhythm, using QTc measurements—a marker of heart electrical function.

How Is the Trial Designed?

Group I: BIIB091, BIIB091-matched placebo, Moxifloxacin-matched placebo Experimental Treatment 3 Interventions

Participants will receive BIIB091, BIIB091-matched placebo, and moxifloxacin-matched placebo orally during the inpatient period (Days -1 to 13).

Group II: Moxifloxacin, Moxifloxacin-matched placebo, BIIB091-matched placebo Active Control 3 Interventions

Participants will receive moxifloxacin, moxifloxacin-matched placebo, and BIIB091-matched placebo orally during the inpatient period (Days -1 to 13).

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/NCT06574828

A Study to Find Out How Multiple Doses of BIIB091 Affect ... In this study, researchers will learn how the heart reacts to multiple doses of BIIB091 in healthy participants. In previous studies looking at BIIB091, ...

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-7-2024-2471e

BIIB091 for Heart Activity in Healthy Subjects The main objective of this study is to learn how the heart's electrical activity changes after taking BIIB091. To measure this, researchers will look at ...

3. 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.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06574828?intr=biib091&aggFilters=studyType:int&viewType=Table&checkSpell=&rank=5

A Study to Find Out How Multiple Doses of BIIB091 Affect ... A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may ...

5. clinconnect.io clinconnect.io/trials/NCT06574828?queryID=0a06c01b0d560e4d9cba&apos=3241

A Study to Find Out How Multiple Doses of BIIB091 Affect This clinical trial is studying how multiple doses of a medication called BIIB091 affect the electrical activity of the heart in healthy volunteers.

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

BIIB091: A Promising New Drug for Multiple Sclerosis ... Heart Safety Study: Researchers are investigating how multiple doses of BIIB091 affect the electrical activity of the heart in healthy participants. Metabolism ...

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

Next‐generation Bruton's tyrosine kinase inhibitor BIIB091 ... BIIB091 blocks B‐cell activation in human healthy volunteers in phase 1 clinical trial. Single and multiple ascending oral doses (SAD/MAD) of ...