A low-intervention prospective-retrospective study to evaluate the pharmacokinetics of elexacaftor/tezacaftor/ivacaftor combination in a Cystic Fibrosis population

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518785-28-00

Acronym

PKCAFTORs

Enrollment

Registered

2025-09-24

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Brief summary

Plasma concentrations of ELX, TEZ and IVA at steady-state (Css).

Detailed description

Population pharmacokinetics (popPK) analysis of ELX, TEZ and IVA at steady state., Harvest of every AE/Adverse Drug Reaction (ADR)., Correlation between PK of ELX, TEZ and IVA and number of AEs, Correlation between PK and ETI efficacy (ppFEV1 and Cl- values at T0) in the 3 groups classifications (responders, non responders and unresolved responders) of ETI

Interventions

DRUGKaftrio 37.5 mg/25 mg/50 mg film-coated tablets

DRUGKalydeco 75 mg film-coated tablets

DRUGKalydeco 150 mg film-coated tablets

DRUGKaftrio 75 mg/50 mg/100 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Plasma concentrations of ELX, TEZ and IVA at steady-state (Css).	—

Secondary

Measure	Time frame
Population pharmacokinetics (popPK) analysis of ELX, TEZ and IVA at steady state., Harvest of every AE/Adverse Drug Reaction (ADR)., Correlation between PK of ELX, TEZ and IVA and number of AEs, Correlation between PK and ETI efficacy (ppFEV1 and Cl- values at T0) in the 3 groups classifications (responders, non responders and unresolved responders) of ETI	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026