NCT01764776

Brief 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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2013

Typical duration for phase_1

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

December 19, 2020

Status Verified

June 1, 2017

Enrollment Period

2 years

First QC Date

January 8, 2013

Last Update Submit

December 16, 2020

Conditions

Normal Hepatic FunctionImpaired Hepatic Function

Keywords

LDE225PharmacokineticsPKPostmenopausal womennormal hepatic functionmild hepatic impairmentmoderate hepatic impairmentsevere hepatic impairment

Outcome Measures

Primary Outcomes (5)

  • LDE225A pharmacokinetic parameter Tmax

    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

    8 weeks

  • LDE225A pharmacokinetic parameter Cmax

    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

    8 weeks

  • LDE225A pharmacokinetic parameter AUClast

    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

    8 weeks

  • LDE225A pharmacokinetic parameter AUCinf

    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

    8 weeks

  • LDE225A pharmacokinetic parameter T1/2

    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

    8 weeks

Secondary Outcomes (4)

  • Occurrence of abnormal safety laboratory parameters

    8 weeks

  • Plasma protein binding of LDE225

    1 day

  • Occurrence of changes in ECGs

    8 weeks

  • Occurrence of adverse event

    8 weeks

Study Arms (1)

LDE225

EXPERIMENTAL

LDE225

Drug: LDE225

Interventions

LDE225DRUG

LDE225

LDE225

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and sterile or postmenopausal female age ≥18 to ≤70 years old.
  • Normal Vital signs
  • Subjects with confirmed cirrhosis
  • Woman of childbearing potential and pregnant or lactating females or male not using condom
  • Risk factors for torsades de pointes
  • Clinically significant cardio-vascular disease
  • severe or uncontrolled medical conditions
  • Smokers consuming greater than 10 cigarettes or equivalent nicotine containing products per day.
  • Use of investigational drugs (i.e. participation in any clinical investigation)
  • Symptoms or history of encephalopathy
  • Clinical evidence of severe ascites

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Miami Div. of Clinical Pharmacology

Miami, Florida, 33136, United States

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Sofia, 1612, Bulgaria

Location

Novartis Investigative Site

Berlin, 14050, Germany

Location

Novartis Investigative Site

Tel Aviv, 64239, Israel

Location

Related Links

MeSH Terms

Interventions

sonidegib

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 8, 2013

First Posted

January 10, 2013

Study Start

March 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

December 19, 2020

Record last verified: 2017-06

Locations

BU(1)US(1)BE(1)DE(1)IL(1)