Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers

Starting soon

Conditions studied: Cystic Fibrosis, Pregnancy

In brief

This study aims to evaluate the pharmacokinetic changes during pregnancy, postpartum, and in breast milk in cystic fibrosis patients receiving a cystic fibrosis transmembrane conductance regulator (CTFR) modulator, including Elexacaftor, Tezacaftor, Ivacaftor, or Lumacaftor.

Key facts

Study ID

NCT04940533

Run by

University of Minnesota

People needed

30

Starts

2027-01-01

Expected to finish

2028-07-01

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female 18 years of age and older
• Female who has a diagnosis of cystic fibrosis
• Female who is taking cystic fibrosis transmembrane conductance regulator (CFTR) modulator medication during pregnancy and postpartum

You may not qualify if…

• Female < 18 years of age
• Female with cystic fibrosis who is not taking cystic fibrosis transmembrane conductance regulator (CFTR) modulator medication during pregnancy and postpartum
• Participant has contraindication to breastfeeding or not planning to breastfeed

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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