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NCT02431481 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT02431481: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02431481 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02431481, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study Summary
The purpose of this study is to characterize the PK and safety profile of LEE011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal renal function.
Primary Outcome
Primary composite PK parameters: Cmax, AUClast, AUCinf, and CL/F. To determine the impact of various degrees of renal impairment on primary PK parameters of LEE011 following a single 400mg oral dose
Interventions
- DRUG LEE011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2015-10-23 |
| Est. Completion | 2018-05-11 |
| Phase | Phase 1 |
What the finished NCT02431481 record still lists
NCT02431481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 1 intervention - of which LEE011 is the first listed.
NCT02431481 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02431481 about?
NCT02431481 is a clinical study titled "Evaluation of Renal Function Impairment on the Pharmacokinetics of LEE011". The purpose of this study is to characterize the PK and safety profile of LEE011 following a single oral dose in adult subjects with various degrees of renal impairment compared to a matched group of healthy subjects with normal renal function.
What is the current status of trial NCT02431481?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2015-10-23. Estimated completion is 2018-05-11.
What interventions are being tested in trial NCT02431481?
The interventions under investigation include: LEE011 (DRUG).
Who is sponsoring clinical trial NCT02431481?
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 NCT02431481's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 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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