A Randomized, Double-Blind, Placebo- and Positive-Controlled (Moxifloxacin), Parallel Study With a Nested Crossover to Assess the Effect of Multiple Oral Therapeutic and Supratherapeutic Doses of BIIB091 on Cardiac Repolarization in Healthy Participants
Abstract
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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 69 participants or records.
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