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

National Jewish Health

Status: Invitation-only

Conditions: Cystic Fibrosis

Study type: Observational

Funder types: Other

Identifiers

NCT05822102

HS-3978

Details and patient eligibility

About

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.

Full description

Blood samples will be collected to measure steady state blood levels for participants who are being treated with elexacaftor/tezacaftor/ivacaftor (ETI). This study is being conducted to evaluate drug dosing in people with cystic fibrosis. The aim of this study is to support clinical validation of pharmacokinetics launch of the elexacaftor/tezacaftor/ivacaftor blood serum level assay to demonstrate instrument capabilities to pass ADx validation criteria.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

100 participants in 1 patient group

People with Cystic Fibrosis who are taking ETI that has reached a steady state dosing level.

Description:

Blood samples will be collected from people with CF who are taking ETI at a continuous dosing regimen for a minimum of 14 days.