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
• Sponsor: Celgene
• Information provided by (Responsible Party): Celgene

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Healthy Volunteers	Drug: ozanimod

Study Design

• Study Type: Observational
• Actual Enrollment: 212 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.	Drug: ozanimod; ozanimod
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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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
2. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 55 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

The approximate number of subjects will be 230 for safety data (from parent studies RPC01-1912, RPC01-1913, and RPC01-1914) and 129 for PK/PD data (from parent studies RPC01-1913 and RPC01-1914).

Criteria

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

Contacts and Locations

Locations

United States, Texas

PPD Phase 1 Clinic

Austin, Texas, United States, 78744

ICON Early Phase Services, LLC

San Antonio, Texas, United States, 78209

Sponsors and Collaborators

Celgene

Investigators

• Study Director: Jonathan Tran, Pharm.D; Celgene

More Information

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT03665610
• Other Study ID Numbers: RPC01-1915; U1111-1219-5905 ( Registry Identifier: WHO )
• First Posted: September 11, 2018
• Last Update Posted: February 6, 2019
• Last Verified: February 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Celgene:

Pharmacodynamics; Pharmacokinetics; Ozanimod; Safety; Healthy Subjects

Additional relevant MeSH terms:

Ozanimod; Sphingosine 1 Phosphate Receptor Modulators; Molecular Mechanisms of Pharmacological Action; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs