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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 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 38 participants.
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.
Interventions
- DRUG LEE011
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2015-10-23 |
| Est. Completion | 2018-05-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02431481
The ClinicalTrials.gov registry entry for NCT02431481 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 38 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.
NCT02431481 reports 0 study locations.
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.
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