69 Participants Needed

BIIB091 for Heart Activity in Healthy Subjects

UB
GB
Overseen ByGlobal Biogen Clinical Trial Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

What is the purpose of this trial?

In this study, researchers will learn how the heart reacts to multiple doses of BIIB091 in healthy participants. In previous studies looking at BIIB091, researchers have found that a certain range of doses can cause changes in the electrical activity of the heart. In this study, researchers want to learn more about that activity after participants take BIIB091 at lower and higher doses for 5 days. 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 something called the QT interval corrected for heartbeat, also known as "QTc". This represents the time it takes for the heart to contract and relax. A QT interval that is too long means that the heart's electrical system is taking longer than normal to recharge between heartbeats. This could increase the risk of abnormal heartbeats that may lead to sudden death.The main questions researchers want to answer are:• What is the change in the participants' QTc after taking BIIB091?Researchers will also learn more about:* Any changes in other measures of the heart's electrical activity* How the body processes BIIB091, as well as something called "M23", which is made in the body when BIIB091 is broken down* Any medical problems the participants have during the study* Any changes in the participants' overall health during the studyThis 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 29 days, after which participants will check into their study research center.* Participants will be randomly assigned to be in 1 of 2 groups: * Group 1: Participants will take a low dose of BIIB091 for 5 days followed by a high dose of BIIB091 for 5 days. * Group 2: Participants will take a single dose of moxifloxacin. Moxifloxacin is an antibiotic used to treat bacterial infections. Researchers are using it in this study to compare to BIIB091, because it is known to cause abnormal changes to the heart's electrical activity. * Participants in both Group 1 and Group 2 will also take a placebo while at the study research center. A placebo looks like the study drug or moxifloxacin, but does not have any real medicine in it.* Participants will remain at their study research center for 15 days. Afterwards, there will be a 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.

Research Team

MD

Medical Director

Principal Investigator

Biogen

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: BIIB091, BIIB091-matched placebo, Moxifloxacin-matched placeboExperimental Treatment3 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 placeboActive Control3 Interventions
Participants will receive moxifloxacin, moxifloxacin-matched placebo, and BIIB091-matched placebo orally during the inpatient period (Days -1 to 13).

Find a Clinic Near You

Who Is Running the Clinical Trial?

Biogen

Lead Sponsor

Trials
655
Recruited
468,000+
Daniel Quirk profile image

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher profile image

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

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

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