NCT04639115

A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild or Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Ozanimod

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

• Liver Diseases
• Digestive System Diseases

Interventions

Type	Name	Description
DRUG	Ozanimod	Ozanimod

Timeline

• Start date: 2020-12-18
• Primary completion: 2022-04-06
• Completion: 2022-04-06
• First posted: 2020-11-20
• Last updated: 2022-06-14

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study