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NCT06574828 · ClinicalTrials.gov registry record · Phase 1
A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart in Healthy Participants
A Phase 1 study, sponsored by Biogen.
- Completed
- Registry status
- Phase 1
- Development phase
- 69
- Enrollment target
NCT06574828 is a Phase 1 study that has completed, run by Biogen. The registered enrollment target is 69 participants.
The verdict
NCT06574828, a Phase 1 study, has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 69 participants
- Enrollment target
Study 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,
Interventions
- DRUG Moxifloxacin
- DRUG BIIB091
- DRUG BIIB091-matched Placebo
- DRUG Moxifloxacin-matched Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2024-08-29 |
| Est. Completion | 2025-03-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06574828
The ClinicalTrials.gov registry entry for NCT06574828 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Moxifloxacin is the first listed.
NCT06574828 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06574828 about?
NCT06574828 is a clinical study titled "A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart in Healthy Participants". 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 ...
What is the current status of trial NCT06574828?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2024-08-29. Estimated completion is 2025-03-22.
What interventions are being tested in trial NCT06574828?
The interventions under investigation include: Moxifloxacin (DRUG), BIIB091 (DRUG), BIIB091-matched Placebo (DRUG), Moxifloxacin-matched Placebo (DRUG).
Who is sponsoring clinical trial NCT06574828?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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