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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001394-25 | EudraCT Number |
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The purpose of this study is to characterize the pharmacokinetics (PK) and safety profile of asciminib following a single oral dose in adult subjects with renal impairment compared to a matched group of healthy subjects with normal renal function.
The results will determine whether or not a dose adjustment should be recommended when treating patients with asciminib who have impaired renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal renal function | Experimental | healthy volunteers with normal renal function |
|
| Severe renal impairment | Experimental | subjects with severe renal impairment |
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| Moderate renal impairment | Experimental | subject with moderate renal impairment |
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| Mild renal impairment | Experimental | subjects with mild renal impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asciminib | Drug | 40 mg single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics: Plasma concentration of asciminib by AUClast | The AUC from time zero to the last measurable concentration sampling time (tlast) (ng*h/mL) | pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose |
| Pharmacokinetics: Plasma concentration of asciminib by AUCinf | The AUC from time zero to infinity (ng*h/mL) | pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose |
| Pharmacokinetics: Plasma concentration of asciminib by Cmax | The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (ng/mL) | pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose |
| Pharmacokinetics: Clearance of asciminib from plasma by CL/F | The total body clearance of drug from the plasma (L/h) | pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Asciminib PK parameters unbound AUClast (AUClast)u and unbound AUCinf (AUCinf)u based on unbound fraction in plasma | including but not limited to: (AUClast)u: area under the unbound plasma concentration-time curve calculated to the last quantifiable concentration point (ng*h/mL)), - (AUCinf)u: unbound plasma concentration-time curve extrapolated to infinity. It is calculated as AUCinf ,u= AUClast ,u+ Clast,u/Lambda_z. (ng*h/mL) |
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Inclusion Criteria:
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 |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Sofia | 1612 | Bulgaria | |||
| Novartis Investigative Site |
| 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 CABL001A2105 can be found on the Novartis Clinical Trial Results Website | View source |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C000621806 | asciminib |
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|
| pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose |
| Asciminib PK parameters unbound Cmax (Cmax)u based on unbound fraction in plasma | The observed maximum unbound plasma concentration following administration (ng/mL) | pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose |
| Asciminib secondary PK parameters Tmax, T1/2 | including but not limited to:
| pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose |
| Asciminib secondary PK parameter AUC0-72h | The area under the unbound plasma concentration-time curve from time zero to 72 h post-dosing (ng*h/mL) | pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose |
| Asciminib secondary PK parameters Vz/F | apparent unbound drug volume of distribution during the terminal elimination phase following extravascular administration | pre-dose (0 hour) and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post-dose |
| Percentage of participants with plasma protein binding as expressed by unbound fraction in plasma | asciminib plasma protein binding in subjects with impaired renal function and subjects with normal renal function | 2 hours post-dose |
| Berlin |
| 14050 |
| Germany |
| A Plain Language Trial Summary is available on novartisclinicaltrials.com | View source |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |