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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 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 30 participants.
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.
Interventions
- DRUG LEE011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2015-03-25 |
| Est. Completion | 2017-01-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02388620
The ClinicalTrials.gov registry entry for NCT02388620 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which LEE011 is the first listed.
NCT02388620 reports 0 study locations.
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.
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