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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT04940533
Status
Not Yet Recruiting

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Conditions

  • Cystic Fibrosis
  • Pregnancy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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 Dates

Start date
Jan 1, 2027
Status verified
Jan 2026
Primary completion
Jul 1, 2028
Completion
Jul 1, 2028

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Participants receiving CFTR modulator therapy - Trikafta
    This is a single arm study. Participants in this study are receiving CFTR modulator therapy.

Primary Outcome Measure

Change in levels of CTFR modulator in blood [ Time Frame: approximately 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Kathine Jacobs, DO
Sabrina Burn, MD (SUB_INVESTIGATOR)

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By research site
University of Minnesota· Minneapolis, MN

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