Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites
|ClinicalTrials.gov Identifier: NCT03665610|
Recruitment Status : Completed
First Posted : September 11, 2018
Last Update Posted : February 6, 2019
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.
|Condition or disease||Intervention/treatment|
|Healthy Volunteers||Drug: ozanimod|
|Study Type :||Observational|
|Actual Enrollment :||212 participants|
|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|
|Actual Study Start Date :||September 10, 2018|
|Actual Primary Completion Date :||January 10, 2019|
|Actual Study Completion Date :||January 10, 2019|
Mandatory Safety Population
All subjects who enrolled in studies RPC01-1912, RPC01-1913, or RPC01-1914 and received at least one dose of ozanimod or IP (per parent studies), excluding subjects who discontinued during Period 1 of study RPC01-1913.
Optional pharmacokinetic(s) and pharmacodynamics(s) population
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 and had no major protocol violations in the parent studies that are deemed to impact PK or PD assessments.
- Adverse events (AEs) [ 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.
- Pharmacodynamics - absolute lymphocyte count (ALC) [ 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
- Pharmacodynamics - lymphocyte subsets [ 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665610
|United States, Texas|
|PPD Phase 1 Clinic|
|Austin, Texas, United States, 78744|
|ICON Early Phase Services, LLC|
|San Antonio, Texas, United States, 78209|
|Study Director:||Jonathan Tran, Pharm.D||Celgene|