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Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis

RecruitingPhase 4Ages 6 Years - anyAllIstituto Giannina Gaslini
NCT07809867 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to support the development of personalized therapy tailored to each patient's individual characteristics. A better understanding of the pharmacokinetic profiles of elexacaftor, tezacaftor, and ivacaftor is essential to support Therapeutic Drug Monitoring (TDM) and to guide dose adjustments when clinically indicated, without compromising therapeutic efficacy. The study will include male and female patients aged ≥6 years with Cystic Fibrosis (CF) carrying at least one F508del mutation and receiving treatment with the elexacaftor/tezacaftor/ivacaftor combination for a sufficient period to achieve steady state. The main objective of the study is to characterize the steady-state plasma concentration profiles of elexacaftor, tezacaftor, and ivacaftor in patients with Cystic Fibrosis treated with the elexacaftor/tezacaftor/ivacaftor combination. Participant

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📋 Eligibility rules (as published)
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.
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What it tests

  • Elexacaftor, Tezacaftor, Ivacaftor
  • Ivacaftor (VX-770)
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Where

1 site
IRCCS Istituto Giannina Gaslini
Genova, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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