NCT03983161

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

A Phase 1 Open-label, Single-dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment Compared With Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Fedratinib	Fedratinib

Timeline

• Start date: 2019-09-04
• Primary completion: 2023-01-05
• Completion: 2023-01-05
• First posted: 2019-06-12
• Last updated: 2023-03-17

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study