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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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05437120
The ClinicalTrials.gov registry entry for NCT05437120 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 179-participant average among 169 other Cystic Fibrosis trials with a reported enrollment target (91% lower). The listed sponsor is Vertex Pharmaceuticals Incorporated, which has 191 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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