Population Pharmacokinetics of Elexacaftor-tezacaftor-ivacaftor in a Paediatric Population

Plain-language summary

This study examines how the medicine combination Elexacaftor/Tezacaftor and Ivacaftor (Trikafta or Kaftrio) is distributed and reaches its levels in the body (its pharmacokinetics) in children with cystic fibrosis. Children aged 2 to 17 with cystic fibrosis who are being treated with this combination can take part. It is a study without an assigned phase and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Recruiting

Sponsor

Hospices Civils de Lyon

Intervention

There is no intervention as this is a prospective pharmacokinetics study.

Start date

2/9/2026

Estimated completion

8/9/2027

Countries

France

Related genes

Locations

• Bron, France

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

* Children aged 2 to 17 years old
* Having Cystic Fibrosis
* Treated by Elexacaftor/Tezacaftor and Ivacaftor (Trikafta® or Kaftrio®)

Exclusion Criteria:

* Allergy to previous CFTR modulator association (Ivacaftor, lumacaftor)
* Pregnant women
* Patient already enrolled in another study with CYP3A4 inhibitor
* Pulmonary transplant recipient