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NCT01764776 · ClinicalTrials.gov registry record · Phase 1
Effect of Hepatic Impairment on LDE225..
A Phase 1 study of Impaired Hepatic Function and Normal Hepatic Function, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 33
- Enrollment target
- 5
- Study locations
NCT01764776: Completed Phase 1 study of Impaired Hepatic Function and Normal Hepatic Function, sponsored by Novartis Pharmaceuticals.
NCT01764776 is a Phase 1 study of Impaired Hepatic Function and Normal Hepatic Function that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 33 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower). The trial reports 5 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01764776, a Phase 1 study of Impaired Hepatic Function and Normal Hepatic Function, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 33 participants
- Enrollment target
- 5
- Study locations
Study Summary
This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
Primary Outcome
Evaluate the pharmacokinetics of a single dose of LDE225 in subjects with impaired hepatic function as compared to healthy subjects for an 8 weeks follow up period
Conditions Studied
Interventions
- DRUG LDE225
Study Locations (5)
Other
- Novartis Investigative Site - Brussels
- Novartis Investigative Site - Sofia
- Novartis Investigative Site - Berlin
- Novartis Investigative Site - Tel Aviv
Florida
- University of Miami Div. of Clinical Pharmacology - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-03 |
| Est. Completion | 2015-03 |
| Phase | Phase 1 |
What the finished NCT01764776 record still lists
NCT01764776 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (45% lower).
The record links to 2 conditions, with Impaired Hepatic Function appearing as the primary indexed condition, and to 1 intervention - of which LDE225 is the first listed.
NCT01764776 lists 5 locations in 2 states (Other, Florida).
Frequently Asked Questions
What is clinical trial NCT01764776 about?
NCT01764776 is a clinical study titled "Effect of Hepatic Impairment on LDE225..". This study is to evaluate the pharmacokinetics and safety of 800 mg of LDE225 in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
What is the current status of trial NCT01764776?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 33 participants. The study started on 2013-03. Estimated completion is 2015-03.
What conditions does trial NCT01764776 study?
This clinical trial studies the following conditions: Impaired Hepatic Function, Normal Hepatic Function.
What interventions are being tested in trial NCT01764776?
The interventions under investigation include: LDE225 (DRUG).
Who is sponsoring clinical trial NCT01764776?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01764776 being conducted?
This trial has 5 study locations across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01764776's enrollment target sits among peer trials
33 1280th of 2000 higher than 705 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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