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The main purpose of this study is to evaluate the effect of varying degrees of impaired hepatic function (by Child-Pugh classification) on the pharmacokinetics (PK) of ABL001 after a single oral dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABL001 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABL001 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Pharmacokinetics (PK): Cmax | To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects | at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose |
| Primary Pharmacokinetics (PK): AUClast | To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects | at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose |
| Primary Pharmacokinetics (PK): AUCinf | To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects | at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose |
| Secondary Pharmacokinetics (PK): Tmax | To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects | at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose |
| Secondary Pharmacokinetics (PK): T 1/2 | To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects | at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of plasma protein binding as expressed by unbound fraction in plasma | To evaluate ABL001 plasma protein binding | 2 hours post-dose |
| ABL001 pharmacokinetic parameter - Cmax - based on unbound fraction in plasma |
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Key Inclusion criteria:
Body mass index of 18-36 kg/m2, with body weight 50 kg and no more than 120 kg
Vital signs (after at least 3 minutes rest in the supine position) within the following ranges (inclusive):
Healthy subjects with no clinically significant abnormalities as determined by past medical history, physical examination, vital signs, ECG, and clinical laboratory test
Subjects with Child-Pugh Clinical Assessment Score as calculated per the Child-Pugh classification
Key Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami / Clinical Research Services, Inc. | Miami | Florida | 33136 | United States | ||
| Orlando Clinical Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34115385 | Derived | Hoch M, Sato M, Zack J, Quinlan M, Sengupta T, Allepuz A, Aimone P, Hourcade-Potelleret F. Pharmacokinetics of Asciminib in Individuals With Hepatic or Renal Impairment. J Clin Pharmacol. 2021 Nov;61(11):1454-1465. doi: 10.1002/jcph.1926. Epub 2021 Jul 16. |
| Label | URL |
|---|---|
| Results for CABL001A2103 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| C000621806 | asciminib |
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| Secondary Pharmacokinetics (PK): CL/F |
To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects |
| at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose |
| Secondary Pharmacokinetics (PK): Vz/F | To evaluate the pharmacokinetics of a single oral dose of ABL001 in subjects with various degrees of impaired hepatic function (by Child-Pugh classification) relative to healthy subjects | at pre- dose (0 hour), 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48, and 72 hours post-dose |
Unbound fraction I plasma includes but is not limited to unbound Cmax (Cmax)
| 2 hours post-dose |
| ABL001 pharmacokinetic parameter - AUClast - based on unbound fraction in plasma | Unbound fraction I plasma includes but is not limited to unbound AUClast (AUClast) | 2 hours post-dose |
| ABL001 pharmacokinetic parameter - AUCinf - based on unbound fraction in plasma | Unbound fraction I plasma includes but is not limited to unbound AUCinf (AUCinf) | 2 hours post-dose |
| Orlando |
| Florida |
| 32809 |
| United States |
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |