Simultaneous quanTification of Elexacaftor/tezAcaftor/Ivacaftor Via Reverse Phase High Performance liquiD chromatographY

Status unconfirmed

Conditions studied: Cystic Fibrosis

In brief

The purpose of this study is to support the clinical validation of a new assay to measure the levels of ivacaftor, tezacaftor, and elexacaftor (the components of Trikafta) in the bloodstream in order to achieve greater understanding of the effectiveness of this medication in all people with cystic fibrosis. Blood will be drawn at 3.0, 4.5, and 6.0 hours after taking the medication in the morning.

Key facts

Study ID

NCT05822102

Run by

National Jewish Health

People needed

100

Starts

2023-02-09

Expected to finish

2023-09-01

Last updated by the study team

2023-07-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Written informed consent obtained from subject
• Diagnosis of CF
• Aged 18 years and older
• Use of ETI that has reached steady state dosing levels of ETI, defined as a continuous dosing regimen for a minimum of 14 days.

You may not qualify if…

• A person with CF (pwCF) that is either not taking ETI or dose not follow a continuous dosing regimen for a minimum of 14 days.
• Use of prohibited medications as outlined by package insert
• Pregnant or lactating people with CF
• Acute, severe deterioration in health requiring intensive care unit admission

Where it is running

• National Jewish Health — Denver, Colorado, United States
• St. Joseph Hospital — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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