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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDE225 | Experimental | LDE225 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDE225 | Drug | LDE225 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of abnormal safety laboratory parameters | Laboratory assessments | 8 weeks |
| Plasma protein binding of LDE225 | Plasma protein binding of LDE225 |
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Inclusion Criteria (all groups):
Inclusion (group mild, moderate and severe hepatic impairment):
-Subjects with confirmed cirrhosis
Exclusion (all groups):
Exclusion for moderate, mild and severe groups:
Exclusion Criteria:
-
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Div. of Clinical Pharmacology | Miami | Florida | 33136 | United States | ||
| Novartis Investigative Site |
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| Label | URL |
|---|---|
| Results for CLDE225A2113 from Novartis Clinical Trials website | View source |
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| ID | Term |
|---|---|
| C561435 | sonidegib |
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| 1 day |
| Occurrence of changes in ECGs | ECGs | 8 weeks |
| Occurrence of adverse event | follow up on any adverse event | 8 weeks |
| Brussels |
| 1200 |
| Belgium |
| Novartis Investigative Site | Sofia | 1612 | Bulgaria |
| Novartis Investigative Site | Berlin | 14050 | Germany |
| Novartis Investigative Site | Tel Aviv | 64239 | Israel |