How the CF medicines elexacaftor, tezacaftor, and ivacaftor behave in the body

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 interventional study aims to characterize the steady-state pharmacokinetic profiles of the three CFTR modulators in patients with cystic fibrosis who are on the approved combination therapy. It includes male and female participants aged 6 years and older with at least one F508del mutation, continuing their usual treatment while pharmacokinetic sampling is conducted. The study seeks to support precision therapy and therapeutic drug monitoring by enabling dose adjustments based on drug concentrations without reducing efficacy. Primary focus is on establishing concentration-time relationships and steady-state levels for elexacaftor, tezacaftor, and ivacaftor. Safety monitoring will be aligned with standard care for participants on this combination regimen.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Cystic Fibrosis patients with at least one F508del mutation treated with the combination elexacaftor/tezacaftor/ivacaftor for a time sufficient to reach steady-state (8 days)
* males and females aged ≥6 years
* informed consent to participate in the study and to process the patient's personal data obtained prior to the collection of any study data.

Exclusion Criteria:

* evidence of inadequate compliance to treatment;
* pregnancy and/or breastfeeding;
* any conditions that may affect the ability to complete informed consent;
* any other severe systemic disorders that may compromise the PK parameters;
* use of any drug capable of moderately/strongly inhibiting or strongly inducing hepatic biotransformation (see section 4 for details);
* denial of the informed consent.

Where it's running

• IRCCS Istituto Giannina Gaslini
  Genova, Italy Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.