Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574828
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
A Study to Find Out How Multiple Doses of BIIB091 Affect the Electrical Activity of the Heart in Healthy Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 hearts 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 hearts 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 hearts 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 hearts 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 participants last dose Each participant will be in the study for up to 53 days
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 hearts 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 hearts 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 participants last dose Each participant will be in the study for up to 53 days
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None