Measuring blood levels of elexacaftor, tezacaftor and ivacaftor in people with cystic fibrosis
Measures drug levels in the blood of people with cystic fibrosis taking this combination.
Plain-language title generated from the registry record
Registry title: Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis
Key facts
- Where
- Florence, Genoa, Milan, and Trieste, ItalySee the 4 sites
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 6 or older with cystic fibrosis who carry at least one F508del mutation and take elexacaftor/tezacaftor/ivacaftor.
- Age
- 6 years or older
- Sex
- Both men and women can join.
- Disease stage
- Cystic fibrosis.
- Earlier treatment
- Must have taken elexacaftor/tezacaftor/ivacaftor long enough to reach steady state (8 days).
- Biomarker or test result
- At least one F508del mutation.
Main reasons for not taking part
- Signs of not taking the treatment properly
- Pregnancy and/or breastfeeding
- Conditions that affect the ability to give informed consent
- Other severe body-wide disorders that may affect drug levels
- Use of drugs that moderately or strongly inhibit, or strongly induce, liver drug breakdown
Read by machine on 9 November 2026.
Where in Italy
- Azienda Ospedaliera Universitaria Meyer IRCCSFlorence, ItalyTaking people
- IRCCS Istituto Giannina GasliniGenoa, ItalyTaking people
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyTaking people
- Istituto Di Ricovero E Cura A Carattere Scientifico Materno Infantile Burlo GarofoloTrieste, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Istituto Giannina Gaslini
- Trial code
- NCT07809867EU 2024-518785-28-00
- Record updated
- 14 October 2026
- Original description
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.Read full original descriptionShow less
A Low-intervention Prospective-retrospective Study to Evaluate the Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Combination in a Cystic Fibrosis Population
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.
Participants will continue their usual treatment with elexacaftor/tezacaftor/ivacaftor and ivacaftor according to the prescribed dosing schedule. During the study, they will attend regular clinical visits every 3 months for up to 12 months.
At these visits, blood samples will be collected as part of routine clinical care and used to measure the plasma concentrations of the study drugs. Additional blood samples may be collected after the morning dose to better characterize drug levels over time. In a subset of participants, additional blood samples may be collected at several time points during the day to further assess the pharmacokinetic profile of the drugs.
A single additional blood sample may be collected for pharmacogenetic analyses. Participants may also undergo a nasal brushing, as part of routine procedures, to obtain nasal epithelial cells for further analyses.
Clinical information, including routine laboratory tests, vital signs, treatment information and any adverse events, will be collected throughout the study. The results of the pharmacokinetic and other laboratory analyses will not be used to modify the participant's treatment, which will remain under the responsibility of the treating physician.
Inclusion: 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: use of any drug capable of moderately/strongly inhibiting or strongly inducing hepatic biotransformation (see section 4 for details); any conditions that may affect the ability to complete informed consent; any other severe systemic disorders that may compromise the PK parameters; evidence of inadequate compliance to treatment; pregnancy and/or breastfeeding; denial of the informed consent.