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A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild or Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Ozanimod
NCT04639115 · View on ClinicalTrials.gov ↗
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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04639115 reports 3 study locations spanning 2 distinct geographic areas — top geographies include Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04639115?
The interventions under investigation include: Ozanimod (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04639115?
This trial is sponsored by Celgene, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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