A Trial to Evaluate the Pharmacokinetics of ABL001 in Healthy and Hepatic Impaired Subjects

Phase 1 Completed 32 enrolled Novartis Pharmaceuticals

NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start: 2016-05-03
Primary completion: 2017-07-20
Completion: 2017-07-20

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Asciminib	Unknown	40 mg	—

Indications

No indication recorded.