A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment

Phase 1 Completed 39 enrolled Celgene Corporation Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation · collab

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 1, multicenter, nonrandomized, open-label, single oral dose study to assess the PK of fedratinib in subjects with moderate and severe hepatic impairment, and in matched subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease.

Timeline

Start: 2019-09-04
Primary completion: 2023-01-05
Completion: 2023-01-05

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Fedratinib	Small molecule	200 mg	Oral
Subject	Fedratinib	Small molecule	300 mg	Oral

Indications

No indication recorded.