Healthy Volunteers Clinical Trial
Official title:
A Phase 1, Multi-center, Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites in Healthy Adult Subjects
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.
n/a
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