A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment
Status:
Recruiting
Trial end date:
2021-12-31
Target enrollment:
Participant gender:
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.
Phase:
Phase 1
Details
Lead Sponsor:
Celgene
Collaborator:
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation