Clinical Trial: A Study to Find Out How BIIB141 (Omaveloxolone) Moves From the Blood Into the Breastmilk of Healthy Women Who Are Breastfeeding or Pumping Milk
Study Status: COMPLETED
Recruit Status: COMPLETED
Condition: Healthy Volunteer
Study Type: INTERVENTIONAL
Official Title: An Open-Label, Single Dose Study to Assess the Breast Milk and Plasma Pharmacokinetics of Omaveloxolone (BIIB141) in Healthy Lactating Women
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 Friedrich's 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…
Read more