A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart in Healthy Participants

NCT06574828 | Completed Phase 1 FDA Drug

• 1 other identifier: 257HV109
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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 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 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 visit 11 to 14 days after each participant's last dose. Each participant will be in the study for up to 57 days.

Conditions

Healthy Volunteer

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (13)

• Change From Baseline in Heart Rate (ΔHR) for BIIB091 and M23

  Baseline (Day -1) up to Day 14

• Change From Baseline in Pulse Rate Interval (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 ECG Morphology for BIIB091 and M23

  From Day -1 up to Day 14

Study Arms (2)

BIIB091, BIIB091-matched placebo, Moxifloxacin-matched placebo

EXPERIMENTAL

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

Drug: BIIB091; Drug: BIIB091-matched Placebo; Drug: Moxifloxacin-matched Placebo

Moxifloxacin, Moxifloxacin-matched placebo, BIIB091-matched placebo

ACTIVE COMPARATOR

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

Drug: Moxifloxacin; Drug: BIIB091-matched Placebo; Drug: Moxifloxacin-matched Placebo

Interventions

BIIB091 DRUG

Administered as specified in the treatment arm.

BIIB091, BIIB091-matched placebo, Moxifloxacin-matched placebo

Moxifloxacin DRUG

Administered as specified in the treatment arm.

Moxifloxacin, Moxifloxacin-matched placebo, BIIB091-matched placebo

BIIB091-matched Placebo DRUG

Administered as specified in the treatment arm.

BIIB091, BIIB091-matched placebo, Moxifloxacin-matched placebo; Moxifloxacin, Moxifloxacin-matched placebo, BIIB091-matched placebo

Moxifloxacin-matched Placebo DRUG

Administered as specified in the treatment arm.

BIIB091, BIIB091-matched placebo, Moxifloxacin-matched placebo; Moxifloxacin, Moxifloxacin-matched placebo, BIIB091-matched placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Have a body mass index between 18 and 32 kilograms per meter square (kg/m\^2), inclusive, and a total body weight \> 50 kg, at screening and Day -2.
• Must be in good health as determined by the Investigator, based on medical history and Screening evaluations.
• Negative polymerase chain reaction (PCR) test result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at check-in (Day -2).

You may not qualify if:

• History of any clinically significant cardiac, endocrine, gastrointestinal, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
• Clinically significant 12-lead ECG findings at screening and prior to first dose, including confirmed demonstration of QTcF \> 430 milliseconds (ms), QRS \> 120 ms, PR \> 220 ms, or heart rate \< 45 beats per minutes (bpm) based on the average of triplicate measurements, early repolarization, or any other clinically significant 12-lead ECG abnormalities as determined by the Investigator.
• History of torsades de pointes or additional risk factors for torsades de pointes.
• History of, or positive test result at Screening for, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus infection.
• Use of any prescription or over-the-counter medication (including herbal supplements) that are known to prolong QT/QTc interval or induce torsades de pointes.
• Chronic, recurrent, or serious infection (e.g., pneumonia, septicemia), as determined by the Investigator, within 90 days prior to Screening or between Screening and Check-in.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Austin Clinic PPD

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

BIIB091; Moxifloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: August 29, 2024
• Primary Completion: March 22, 2025
• Study Completion: March 22, 2025
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)