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NCT02388620 · ClinicalTrials.gov registry record · Phase 1
Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT02388620: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT02388620 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02388620, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function (based on Child-Pugh classification) as compared to demographically-matched control subjects with normal hepatic function.
Primary Outcome
PK profile includes the following parameters Tmax, Cmax, AUClast, AUCinf, T1/2, CL/F, Vz/F.
Interventions
- DRUG LEE011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-03-25 |
| Est. Completion | 2017-01-09 |
| Phase | Phase 1 |
What the finished NCT02388620 record still lists
NCT02388620 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which LEE011 is the first listed.
NCT02388620 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02388620 about?
NCT02388620 is a clinical study titled "Evaluation of Hepatic Function Impairment on the Pharmacokinetics of LEE011". The purpose of this study is to evaluate the pharmacokinetics (PK), safety and tolerability of a single oral dose of LEE011 in subjects with varying degrees of impaired hepatic function (based on Child-Pugh classification) as compared to demographically-matched control subjects with normal hepatic f...
What is the current status of trial NCT02388620?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2015-03-25. Estimated completion is 2017-01-09.
What interventions are being tested in trial NCT02388620?
The interventions under investigation include: LEE011 (DRUG).
Who is sponsoring clinical trial NCT02388620?
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 NCT02388620's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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