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NCT05437120 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment
A Phase 1 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 2
- Study locations
NCT05437120: Completed Phase 1 study of Cystic Fibrosis, sponsored by Vertex Pharmaceuticals Incorporated.
NCT05437120 is a Phase 1 study of Cystic Fibrosis that has completed, run by Vertex Pharmaceuticals Incorporated. The registered enrollment target is 16 participants, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05437120, a Phase 1 study of Cystic Fibrosis, has completed, sponsored by Vertex Pharmaceuticals Incorporated.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with moderate hepatic impairment and in matched healthy participants.
Conditions Studied
Interventions
- DRUG VX-121/TEZ/D-IVA
Study Locations (2)
Florida
- Clinical Pharmacology of Miami, LLC - Miami
- GCP Research - St. Petersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2022-07-22 |
| Est. Completion | 2023-03-16 |
| Phase | Phase 1 |
What the finished NCT05437120 record still lists
NCT05437120 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Cystic Fibrosis appearing as the primary indexed condition, and to 1 intervention - of which VX-121/TEZ/D-IVA is the first listed.
NCT05437120 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05437120 about?
NCT05437120 is a clinical study titled "Pharmacokinetics and Safety Assessment of VX-121/Tezacaftor/Deutivacaftor in Participants With Moderate Hepatic Impairment". The purpose of this study is to evaluate the pharmacokinetics (PK) and safety of VX-121/tezacaftor/deutivacaftor (VX-121/TEZ/D-IVA) in participants with moderate hepatic impairment and in matched healthy participants.
What is the current status of trial NCT05437120?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2022-07-22. Estimated completion is 2023-03-16.
What conditions does trial NCT05437120 study?
This clinical trial studies the following conditions: Cystic Fibrosis.
What interventions are being tested in trial NCT05437120?
The interventions under investigation include: VX-121/TEZ/D-IVA (DRUG).
Who is sponsoring clinical trial NCT05437120?
This trial is sponsored by Vertex Pharmaceuticals Incorporated, which has 191 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05437120 being conducted?
This trial has 2 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cystic Fibrosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05437120's enrollment target sits among peer trials
16 140th of 169 higher than 26 of 169 other Cystic Fibrosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cystic Fibrosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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