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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 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. The trial reports 5 study locations across 2 states.

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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.

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

FieldValue
Enrollment Target 33 participants
Start Date 2013-03
Est. Completion 2015-03
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01764776

The ClinicalTrials.gov registry entry for NCT01764776 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 33 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 2 conditions, with Impaired Hepatic Function appearing as the primary indexed condition, and to 1 intervention - of which LDE225 is the first listed.

NCT01764776 reports 5 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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