Status:
COMPLETED
A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart in Healthy Participants
Lead Sponsor:
Biogen
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 ...
Detailed Description
The primary objective of this study is to evaluate the effect of BIIB091 and its metabolite M23 following multiple therapeutic and supratherapeutic doses of BIIB091 on QTc intervals in healthy partici...
Eligibility Criteria
Inclusion
- Key Inclusion criteria:
- 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).
- Key Exclusion Criteria:
- 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.
- NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Exclusion
Key Trial Info
Start Date :
August 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 22 2025
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT06574828
Start Date
August 29 2024
End Date
March 22 2025
Last Update
March 28 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Austin Clinic PPD
Austin, Texas, United States, 78744