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NCT04587622 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT04587622: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT04587622 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04587622, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics, safety, and tolerability of icenticaftor in participants with varying degrees of hepatic impairment.
Primary Outcome
Icenticaftor plasma concentrations will be determined by a validated liquid chromatography with tandem mass spectrometry (LC-MS/MS) method. Cmax of icenticaftor will be determined with Phoenix WinNonlin (Version 6.4 or higher).
Interventions
- DRUG Icenticaftor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-10-30 |
| Est. Completion | 2022-09-15 |
| Phase | Phase 1 |
What the finished NCT04587622 record still lists
NCT04587622 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which Icenticaftor is the first listed.
NCT04587622 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04587622 about?
NCT04587622 is a clinical study titled "Pharmacokinetic Study of Icenticaftor in Participants With Hepatic Impairment". The primary purpose of this study is to evaluate the effect of hepatic impairment on the systemic pharmacokinetics, safety, and tolerability of icenticaftor in participants with varying degrees of hepatic impairment.
What is the current status of trial NCT04587622?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2020-10-30. Estimated completion is 2022-09-15.
What interventions are being tested in trial NCT04587622?
The interventions under investigation include: Icenticaftor (DRUG).
Who is sponsoring clinical trial NCT04587622?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04587622's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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