A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart in Healthy Participants
NCT Number: NCT06574828
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Healthy Volunteer
Interventions: DRUG: BIIB091|DRUG: Moxifloxacin|DRUG: BIIB091-matched Placebo|DRUG: Moxifloxacin-matched Placebo
Sponsor: Biogen
Sex: ALL
Age: ADULT
Enrollment: 64
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-29
Completion Date: 2024-11-27

Summary:
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 looked 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 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 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 phone call 7 to 10 days after each participant's last dose. Each participant will be in the study for up to 53 days.

Primary Outcome Measures: Change From Baseline in QT Interval Corrected for Heart Rate (QTc) for BIIB091, Baseline (Day -1) up to Day 14|Change From Baseline in QT Interval Corrected for Heart Rate (QTc) for Metabolite 23 (M23), Baseline (Day -1) up to Day 14
Secondary Outcome Measures: Change From Baseline in Heart Rate (HR [ΔHR]) for BIIB091 and M23, Baseline (Day -1) up to Day 14|Change From Baseline in Pulse Rate Interval (PR [ΔPR]) for BIIB091 and M23, Baseline (Day -1) up to Day 14|Change From Baseline in QRS Interval (ΔQRS) for BIIB091 and M23, Baseline (Day -1) up to Day 14|Number of Participants With Categorical Outliers for QT Interval Corrected Formula for Heart Rate (QTcF), HR, PR, and QRS for BIIB091 and M23, From Day -1 up to Day 14|Number of Participants With Treatment-Emergent Changes in Electrocardiogram (ECG) Morphology for BIIB091 and M23, From Day -1 up to Day 14|Time to Maximum Measured Plasma Concentration (Tmax) of BIIB091 and M23, Pre-dose and at multiple timepoints up to Day 14|Maximum Measured Plasma Concentration (Cmax) of BIIB091 and M23, Pre-dose and at multiple timepoints up to Day 14|Area Under the Plasma Concentration Versus Time Curve to 24 Hours (AUC0-24) of BIIB091 and M23, Pre-dose and at multiple timepoints up to Day 14|Area Under the Plasma Concentration Versus Time Curve to the Last Measurable Concentration (AUC0-t) of BIIB091 and M23, Pre-dose and at multiple timepoints up to Day 14|Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs), From Day 1 up to end of study follow-up (up to 53 days)|Number of Participants With Clinically Significant Vital Signs Abnormalities, From Day -1 up to Day 14|Number of Participants With ECG Abnormalities, From Day 1 up to Day 14|Number of Participants With Clinically Significant Laboratory Assessment Abnormalities, From Day 1 up to Day 14