Ozanimod
Drugozanimod
NCT Number: NCT03665610
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.
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Notify Me18 year–55 year
All sexes
Observational
PPD Phase 1 Clinic, Austin, Texas, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No Exclusion Criteria
ozanimod
Time frame: From enrollment up to 75 +/- 10 days after the last dose in the parent study (RPC01-1912, RPC01-1913, or RPC01-1914)
The incidence, severity, and relationship of TEAEs.
Time frame: Up to 75 +/- 10 days after the last dose in the parent study (RPC01-1913 or RPC01-1914)
The absolute lymphocyte count (ALC) will be determined via hematology test
Time frame: Up to 75 +/- 10 days after the last dose in the parent study (RPC01-1913 or RPC01-1914)
Lymphocyte subsets will be measured using the immune cell monitoring epigenetic platform
Celgene
Industry
A Phase 1, Multi-center, Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites in Healthy Adult Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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