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Clinical Trial Summary

This is a prospective, single-center, fixed-sequence, nonrandomized, open-label study in healthy adults to investigate the impact of rifabutin on the pharmacokinetics of trikafta.


Clinical Trial Description

Trikafta (Elexacaftor [ELX], Tezacaftor [TEZ], Ivacaftor[IVA]) is contraindicated with concomitant use of strong inducers as co-administration of rifampin decreased the area-under-the concentration time curve (AUC) of IVA by 89%, creating a therapeutic challenge to the treatment of non-tuberculosis mycobacteria (NTM) infection in people with cystic fibrosis (CF). While rifabutin also induces CYP3A4 activity, its effects appear to be more moderate when compared with rifampin. Therefore, we hypothesize that rifabutin can be co-administered with an adjusted dose of ELX/TEZ/IVA in patients being treated for NTM pulmonary disease. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04840862
Study type Interventional
Source University of Southern California
Contact Paul M. Beringer, PharmD
Phone 323-442-1402
Email beringer@usc.edu
Status Recruiting
Phase Phase 4
Start date May 9, 2022
Completion date May 2024

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