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

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ClinicalTrials.gov Identifier: NCT03665610
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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 Type : Observational
Estimated Enrollment : 230 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
Estimated Primary Completion Date : January 16, 2019
Estimated Study Completion Date : May 21, 2019

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.



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



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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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665610


Contacts
Contact: Associate Director Clinical Trial Disclosure 1-888-260-1599 clinicaltrialdisclosure@celgene.com

Locations
United States, Texas
PPD Phase 1 Clinic Not yet recruiting
Austin, Texas, United States, 78744
PPD Phase 1 Clinic Recruiting
Austin, Texas, United States, 78744
ICON Early Phase Services, LLC Not yet recruiting
San Antonio, Texas, United States, 78209
ICON Early Phase Services, LLC Recruiting
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Celgene
Investigators
Study Director: Jonathan Tran, Pharm.D Celgene

Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT03665610     History of Changes
Other Study ID Numbers: RPC01-1915
U1111-1219-5905 ( Registry Identifier: WHO )
First Posted: September 11, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

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