Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites

• Sponsor: Celgene (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03665610
• Collaborator: (none)
• Enrollment: 212
• Locations: 2
• Actual Duration (Months): 4
• Patients Per Site: 106
• Patients Per Site Per Month: 26.4

Study Details

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	Phase
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: Sep 10, 2018
• Actual Primary Completion Date: Jan 10, 2019
• Actual Study Completion Date: Jan 10, 2019

Arms and Interventions

Arm	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) [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) [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 [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

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

3. 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.

4. Subjects had no major protocol violations in the parent studies that are deemed to impact PK or PD assessments.

5. 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

	Site	City	State	Country	Postal Code
1	PPD Phase 1 Clinic	Austin	Texas	United States	78744
2	ICON Early Phase Services, LLC	San Antonio	Texas	United States	78209

Sponsors and Collaborators

• Celgene

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Celgene
• ClinicalTrials.gov Identifier: NCT03665610
• Other Study ID Numbers: RPC01-1915; U1111-1219-5905
• First Posted: Sep 11, 2018
• Last Update Posted: Feb 6, 2019
• Last Verified: Feb 1, 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

Study Results

No Results Posted as of Feb 6, 2019