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NCT07809867

Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis

StatusRecruiting
PhasePhase 4
Primary completion (estimated)

At risk: Primary endpoint(s) modified.

See at-risk trials from Istituto Giannina Gaslini

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Record History

All 3 versions: 3 with changes below. See every version on ClinicalTrials.gov ↗

  1. Recruitment opened
    • Start date changed from estimate of Sep 2026 to Sep 18, 2026
  2. Primary endpoint(s) modified
    • Secondary endpoints revised (4)
    • Eligibility criteria expanded, about 1 word
  3. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Plasma concentrations of elexacaftor, tezacaftor and ivacaftor at steady-state
Timeframe: [Visit 1 - Day 0] [Visit 2 - Day 90±5] [Visit 3 - Day 180±5]

Secondary (4)

Population pharmacokinetics (popPK) analysis of elexacaftor, tezacaftor and ivacaftor at steady state
Harvest of every Adverse Event (AE)/Adverse Drug Reaction (ADR)
Correlation between pharmacokinetics of elexacaftor, tezacaftor and ivacaftor and number of Adverse Event (AE)
Correlation between pharmacokinetics and elexacaftor, tezacaftor and ivacaftor efficacy in the 3 groups classifications (responders, non responders and unresolved responders) of elexacaftor, tezacaftor and ivacaftor

Arms and interventions

Elexacaftor/Tezacaftor/Ivacaftor + IvacaftorExperimental

Drugs: Elexacaftor, Tezacaftor, Ivacaftor, Ivacaftor (VX-770)

Sites

1 site in 1 country

  • IRCCS Istituto Giannina GasliniGenova, Italy