Effect of Hepatic Impairment on LDE225..

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01764776
• Date of registration: 08/01/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: Effect of Hepatic Impairment on LDE225..
• Scientific title: A Phase I, Open Label, Multi-center, Single Dose Study to Evaluate the Pharmacokinetics of LDE225 in Healthy Subjects With Normal Hepatic Function and Subjects With Impaired Hepatic Function.
• Date of first enrolment: March 2013
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01764776
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Belgium, Bulgaria, Germany, Israel, Russian Federation, United States

Contacts

• Name: Novartis Pharmaceuticals
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria (all groups):

- Male and sterile or postmenopausal female age =18 to =70 years old.

- Normal Vital signs

Inclusion (group mild, moderate and severe hepatic impairment):

-Subjects with confirmed cirrhosis

Exclusion (all groups):

- 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)

Exclusion for moderate, mild and severe groups:

- Symptoms or history of encephalopathy

- Clinical evidence of severe ascites

Exclusion Criteria:



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Impaired Hepatic Function

Normal Hepatic Function

Intervention(s)

Drug: LDE225

Primary Outcome(s)

LDE225A pharmacokinetic parameter AUCinf [Time Frame: 8 weeks]

LDE225A pharmacokinetic parameter Cmax [Time Frame: 8 weeks]

LDE225A pharmacokinetic parameter Tmax [Time Frame: 8 weeks]

LDE225A pharmacokinetic parameter T1/2 [Time Frame: 8 weeks]

LDE225A pharmacokinetic parameter AUClast [Time Frame: 8 weeks]

Secondary Outcome(s)

Occurrence of abnormal safety laboratory parameters [Time Frame: 8 weeks]

Occurrence of changes in ECGs [Time Frame: 8 weeks]

Occurrence of adverse event [Time Frame: 8 weeks]

Plasma protein binding of LDE225 [Time Frame: 1 day]

Secondary ID(s)

CLDE225A2113

Source(s) of Monetary Support

Please refer to primary and secondary sponsors