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NCT04639115 · ClinicalTrials.gov registry record · Phase 1
A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild or Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Ozanimod
A Phase 1 study of Liver Diseases and Digestive System Diseases, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 3
- Study locations
NCT04639115 is a Phase 1 study of Liver Diseases and Digestive System Diseases that has completed, run by Celgene. The registered enrollment target is 26 participants, below the 61,158-participant average among 33 other Liver Diseases trials with a reported enrollment target (100% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT04639115, a Phase 1 study of Liver Diseases and Digestive System Diseases, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a Phase 1, multicenter, nonrandomized, open-label, parallel-group study in participants with mild or moderate hepatic impairment, and in participants with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the participant's score according to Pugh's Modification of Child's Classification of Severity of Liver Disease. Participants will be enrolled in Groups 1 through 3 as follows: * Group 1 (mild hepatic impairment): A total of approximately 8 participants with a Child-Pugh score of 5 to 6. * Group 2 (moderate hepatic impairment): A total of approximately 8 participants with a Child-Pugh score of 7 to 9. * Group 3 (normal hepatic function): Approximately 8 to 16 participants will be matched to Participants in Groups 1 and 2. Normal hepatic function participants are allowed to match multiple hepatic impairment participants. Participants will be matched by sex, age (± 10 years), weight (± 20%), and smoking status.
Conditions Studied
Interventions
- DRUG Ozanimod
Study Locations (3)
Florida
- University of Miami Miller School of Medicine - Miami
- Orlando Clinical Research Center OCRC - Orlando
Texas
- The Texas Liver Institute - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2020-12-18 |
| Est. Completion | 2022-04-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04639115
The ClinicalTrials.gov registry entry for NCT04639115 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 61,158-participant average among 33 other Liver Diseases trials with a reported enrollment target (100% lower). The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Liver Diseases appearing as the primary indexed condition, and to 1 intervention - of which Ozanimod is the first listed.
NCT04639115 reports 3 study locations spanning 2 distinct geographic areas - top geographies include Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT04639115 about?
NCT04639115 is a clinical study titled "A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild or Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Ozanimod". This is a Phase 1, multicenter, nonrandomized, open-label, parallel-group study in participants with mild or moderate hepatic impairment, and in participants with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the participant's score according to Pugh'...
What is the current status of trial NCT04639115?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2020-12-18. Estimated completion is 2022-04-06.
What conditions does trial NCT04639115 study?
This clinical trial studies the following conditions: Liver Diseases, Digestive System Diseases.
What interventions are being tested in trial NCT04639115?
The interventions under investigation include: Ozanimod (DRUG).
Who is sponsoring clinical trial NCT04639115?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04639115 being conducted?
This trial has 3 study locations across Florida, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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