BIIB091 for Heart Activity in Healthy Subjects
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
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
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either BIIB091 or moxifloxacin, along with placebos, to assess the effect on cardiac repolarization
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- BIIB091
Find a Clinic Near You
Who Is Running the Clinical Trial?
Biogen
Lead Sponsor
Daniel Quirk
Biogen
Chief Medical Officer
MD
Christopher A. Viehbacher
Biogen
Chief Executive Officer since 2022
Graduated from Queen's University, Kingston, Ontario, Canada