Trials / Unknown
UnknownNCT05822102
Simultaneous quanTification of Elexacaftor/tezAcaftor/Ivacaftor Via Reverse Phase High Performance liquiD chromatographY
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- National Jewish Health · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed 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.
Conditions
Timeline
- Start date
- 2023-02-09
- Primary completion
- 2023-09-01
- Completion
- 2023-09-01
- First posted
- 2023-04-20
- Last updated
- 2023-07-24
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05822102. Inclusion in this directory is not an endorsement.