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Pharmacokinetics and safety of 750 mg of LDK378 given once orally in subjects with impaired hepatic function and healthy subjects with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Hepatic Function | Experimental | Subjects with normal hepatic function |
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| Mild Hepatic Impairment | Experimental | Subjects with mild hepatic impairment |
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| Moderate Hepatic Impairment | Experimental | Subjects with moderate hepatic impairment |
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| Severe Hepatic Impairment | Experimental | Subjects with severe hepatic impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LDK378 | Drug | Oral LDK378 750 mg once |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDK378 pharmacokinetic parameters (Tmax) | Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects | 18 Days |
| LDK378 pharmacokinetic parameters ( Cmax) | Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects | 18 Days |
| LDK378 pharmacokinetic parameters ( AUClast) | Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects | 18 Days |
| LDK378 pharmacokinetic parameters (AUCinf) | Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects | 18 Days |
| LDK378 pharmacokinetic parameters (T1/2) | Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects | 18 Days |
| LDK378 pharmacokinetic parameters (CL/F) | Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects | 18 Days |
| LDK378 pharmacokinetic parameters (Vz/F) | Evaluate the pharmacokinetics of a single dose of LDK378 in subjects with impaired hepatic function as compared to healthy subjects |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with Adverse events | Safety will be determined by the frequency of adverse events and the frequency of laboratory toxicities. | after informed consent is signed, 30 days after last dose |
| Plasma protein binding of LDK378 |
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Inclusion Criteria (all groups):
Inclusion (group mild, moderate and severe hepatic impairment):
- Subjects with confirmed cirrhosis
Exclusion Criteria (all groups):
Exclusion Criteria (moderate, mild and severe groups):
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita Clinical Research-Denver | Lakewood | Colorado | 80228 | United States | ||
| Avail. Clinical Research, LLC |
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| Label | URL |
|---|---|
| Results for CLDK378A2110 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| C586847 | ceritinib |
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| 18 Days |
Plasma protein binding of LDK378
| Day 1 predose, Day 1 6 hours postdose |
| DeLand |
| Florida |
| 32720 |
| United States |
| Clinical Research of Miami, INC CLDK378A2110 | Miami | Florida | 33126 | United States |
| Orlando Clinical Research Center | Orlando | Florida | 32086 | United States |
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |