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JAK2 Inhibitor

Fedratinib for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Celgene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until at least 30 days after completion of study treatment
Awards & highlights

Study Summary

This trial will study the effects of a new drug, fedratinib, on different degrees of liver disease. The subjects' liver function will be classified according to Pugh's Modification of Child's Classification, and they will be given a single oral dose of the drug. The trial will assess the drug's pharmacokinetics in these subjects.

Eligible Conditions
  • Healthy Subjects
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until at least 30 days after completion of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until at least 30 days after completion of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Fedratinib Pharmacokinetic (PK): AUC0-t
Fedratinib Pharmacokinetic (PK): AUC0-∞
Fedratinib Pharmacokinetic (PK): CL/F
+4 more
Secondary outcome measures
Adverse Events (AEs)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Fedratinib in severe hepatic impairment subjectsExperimental Treatment1 Intervention
A single dose of 200 mg of fedratinib will be given to subjects with severe hepatic impairment
Group II: Fedratinib in moderate hepatic impairment subjectsExperimental Treatment1 Intervention
A single oral dose of 300 mg of fedratinib will be given to subjects with moderate hepatic impairment
Group III: Fedratinib in healthy vs severe hepatic impairment subjectsExperimental Treatment1 Intervention
A single oral dose of 200 mg of fedratinib will be given to healthy subjects with normal hepatic function.
Group IV: Fedratinib in healthy vs moderate hepatic impairment subjectsExperimental Treatment1 Intervention
A single oral dose of 300 mg of fedratinib will be given to healthy subjects with normal hepatic function.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fedratinib
2019
Completed Phase 1
~190

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

CelgeneLead Sponsor
636 Previous Clinical Trials
128,932 Total Patients Enrolled
Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene CorporationIndustry Sponsor
6 Previous Clinical Trials
325 Total Patients Enrolled
Leon Carayannopoulos, MDStudy DirectorCelgene Corporation
14 Previous Clinical Trials
519 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment
2019. "A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03983161.
~7 spots leftby Apr 2025
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