A Pharmacokinetics and Tolerability Study of Fedratinib in Subjects With Moderate and Severe Hepatic Impairment
Public ClinicalTrials.gov record NCT03983161. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT03983161
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Lead sponsor
- Celgene
- Industry
- Enrollment
- 39 participants
Conditions and interventions
Conditions
Interventions
- Fedratinib Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 3, 2019
- Primary completion
- Jan 4, 2023
- Completion
- Jan 4, 2023
- Last update posted
- Mar 16, 2023
2019 – 2023
United States locations
- U.S. sites
- 3
- U.S. states
- 2
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Of Miami Miller School Of Medicine | Miami | Florida | 33136 | — |
| Orlando Clinical Research Center OCRC | Orlando | Florida | 32809 | — |
| Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville | Knoxville | Tennessee | 37920 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03983161, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 16, 2023 · Synced Jul 22, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03983161 live on ClinicalTrials.gov.