NCT07809867 Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis
| NCT ID | NCT07809867 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Istituto Giannina Gaslini |
| Condition | Cystic Fibrosis (CF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-09-18 |
| Primary Completion | 2028-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 50 participants in total. It began in 2026-09-18 with a primary completion date of 2028-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT07809867 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, studying Cystic Fibrosis (CF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07809867 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07809867 currently recruiting?
Yes, NCT07809867 is actively recruiting participants. Visit ClinicalTrials.gov or contact Istituto Giannina Gaslini to inquire about joining.
Where is the NCT07809867 trial being conducted?
This trial is being conducted at Genova, Italy.
Who is sponsoring the NCT07809867 clinical trial?
NCT07809867 is sponsored by Istituto Giannina Gaslini. The trial plans to enroll 50 participants.