Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06612879
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
A Study to Find Out How BIIB141 Omaveloxolone Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Single Dose Study to Assess the Breast Milk and Plasma Pharmacokinetics of Omaveloxolone BIIB141 in Healthy Lactating Women
Status:
NOT_YET_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 BIIB141 also known as omaveloxolone or SKYCLARYS moves through the body This is a drug available for doctors to prescribe for patients with Friedrichs Ataxia But this drug has not yet been tested in women who have recently given birth and are breastfeeding or pumping milk for their babies So researchers do not know how much of the drug could be passed on to babies through the breastmilk of mothers who may take BIIB141
The main objective of this study is to learn how a single dose of BIIB141 is processed in both the breastmilk and in the blood of healthy women who are breastfeeding
The main question researchers want to answer in this study is
How does BIIB141 move from the blood into the breastmilk
Researchers will also learn more about
How BIIB141 moves through the blood
What dose of BIIB141 a baby may get from the mothers breastmilk
Any medical problems the participants have 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 28 days after which participants will check into their study research center
Participants will take a single dose of BIIB141 as a tablet by mouth on Day 1
Participants will remain at their study research center for 6 days During this time the participants will be provided with an electric breast pump This is so that the researchers can collect breastmilk samples before and after the participants take BIIB141 The researchers will also collect blood samples
After leaving the study research center the participants will return every 2 days for the next 10 days for more tests and checkups
Finally there will be a follow-up with a lactation consultant up to 30 days after each participants last study visit This is someone who can help participants with breastfeeding or pumping
Each participant will be in the study for up to 25 months
The main objective of this study is to learn how a single dose of BIIB141 is processed in both the breastmilk and in the blood of healthy women who are breastfeeding
The main question researchers want to answer in this study is
How does BIIB141 move from the blood into the breastmilk
Researchers will also learn more about
How BIIB141 moves through the blood
What dose of BIIB141 a baby may get from the mothers breastmilk
Any medical problems the participants have 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 28 days after which participants will check into their study research center
Participants will take a single dose of BIIB141 as a tablet by mouth on Day 1
Participants will remain at their study research center for 6 days During this time the participants will be provided with an electric breast pump This is so that the researchers can collect breastmilk samples before and after the participants take BIIB141 The researchers will also collect blood samples
After leaving the study research center the participants will return every 2 days for the next 10 days for more tests and checkups
Finally there will be a follow-up with a lactation consultant up to 30 days after each participants last study visit This is someone who can help participants with breastfeeding or pumping
Each participant will be in the study for up to 25 months
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