NCT03665610

Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites

A Phase 1, Multi-center, Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites in Healthy Adult Subjects

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 212 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

Study Design This is a Phase 1, multi-center, extension study to collect safety data up to 75 ± 10 days postdose from the Phase 1 studies RPC01-1912, RPC01-1913 and RPC01-1914 (ie, the "parent studies") and PK/PD data up to 75 ± 10 days postdose from studies RPC01-1913 and RPC01-1914. This study consists of two parts: * Mandatory data collection for safety: Subjects enrolled in the parent studies were consented to have data on adverse events (AEs), serious adverse events (SAEs), pregnancy test results, and concomitant medications up to the 75 ± 10 days postdose follow-up collected and reported in this study. * Optional sparse sampling for PK/PD: Eligible subjects from studies RPC01-1913 and RPC01-1914 will be offered the opportunity to return to the clinical research unit (CRU) at four separate occasions for PK/PD sample collections up to the 75 ± 10 days postdose follow-up. After signing the informed consent form, eligible subjects will be randomized to one of three sequences with stratification by site/protocol. Subjects will return to the CRU in the morning (between approximately 8 am and 11 am) once at each of the four time windows. Study Population The approximate number of subjects will be 230 for safety data and 129 for PK/PD data. Length of Study The study duration is up to 84 days.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ozanimod	ozanimod

Timeline

• Start date: 2018-09-10
• Primary completion: 2019-01-10
• Completion: 2019-01-10
• First posted: 2018-09-11
• Last updated: 2019-02-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study