Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 2/8/2019 |
| Start Date: | September 10, 2018 |
| End Date: | January 10, 2019 |
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.
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.
Inclusion Criteria:
1. For the mandatory data collection for safety, subjects who enrolled in the Phase 1
studies RPC01-1912, RPC01-1913, or RPC01-1914 and received at least one dose of
ozanimod or investigational product (IP) as applicable per the parent studies are
eligible, except for subjects who discontinued during Period 1 of study RPC01-1913.
2. For the optional sparse sampling for PK/PD, subjects must satisfy the following
criteria:
1. Subjects in study RPC01-1913 have completed the study at least through Period 2
and completed the 7 ± 2 days postdose follow-up assessments; or subjects in study
RPC01-1914 have completed the study through the 7 ± 2 days postdose follow-up.
2. Subjects had no major protocol violations in the parent studies that are deemed
to impact PK or PD assessments.
3. Subjects must be able to comprehend and provide written informed consent, and
must be able to comply with the requirements of the study, including the study
visit schedule and other protocol requirements or restrictions.
Exclusion Criteria:
No Exclusion Criteria
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