Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study of Liver Diseases and Digestive System Diseases, sponsored by Celgene.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
AUC from time zero to the last measured time point
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 |
What the finished NCT04639115 record still lists
NCT04639115 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 61,158-participant average among 33 other Liver Diseases trials with a reported enrollment target (100% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Liver Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04639115's enrollment target sits among peer trials
26 29th of 33 higher than 5 of 33 other Liver Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Liver Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
The Microbiota Augmentation to Reestablish Commensal Organisms (MARCO) Trial
RECRUITING · Phase 1
-
Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients
COMPLETED · Phase 1
-
A Study to Test How Zongertinib is Taken up in the Blood of People With and Without Liver Problems
COMPLETED · Phase 1
-
Veteran-Centered Care for Advanced Liver Disease (Vet-CALD)
RECRUITING · NA
-
Enhancing Alcohol Treatment Engagement in Associated Liver Disease (ALD) Patients
RECRUITING · NA
-
MAsS Scan as a Predictor of Morbidity and Mortality in Patients With Liver Disease
RECRUITING
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02646475 · 26 participants · Phase 1
Metabolic Effects of Angiotensin-(1-7)
- NCT03603223 · 26 participants · Phase 2
Pembrolizumab in Treating Participants With Leukoplakia
- NCT04063592 · 26 participants · NA
AMI Construction in Lower Extremity Residual Limbs
- NCT04906460 · 26 participants · Phase 1
Open-label Study of WVE-N531 in Patients With Duchenne Muscular Dystrophy (FORWARD-53)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI