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

NCT03665610 | Completed FDA Drug

• 2 other identifiers: RPC01-1915U1111-1219-5905
• Study Type: observational
• Target: 212
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Volunteers

Keywords

Pharmacodynamics; Pharmacokinetics; Ozanimod; Safety; Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs)

  The incidence, severity, and relationship of TEAEs.

  From enrollment up to 75 +/- 10 days after the last dose in the parent study (RPC01-1912, RPC01-1913, or RPC01-1914)

Secondary Outcomes (2)

• Pharmacodynamics - absolute lymphocyte count (ALC)

  Up to 75 +/- 10 days after the last dose in the parent study (RPC01-1913 or RPC01-1914)

• Pharmacodynamics - lymphocyte subsets

  Up to 75 +/- 10 days after the last dose in the parent study (RPC01-1913 or RPC01-1914)

Study Arms (2)

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

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.

Interventions

ozanimod DRUG

ozanimod

Mandatory Safety Population

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

• 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.
• For the optional sparse sampling for PK/PD, subjects must satisfy the following criteria:
• 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.
• Subjects had no major protocol violations in the parent studies that are deemed to impact PK or PD assessments.
• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (2)

PPD Phase 1 Clinic

Austin, Texas, 78744, United States

Location

ICON Early Phase Services, LLC

San Antonio, Texas, 78209, United States

Location

MeSH Terms

Interventions

ozanimod

Study Officials

• Jonathan Tran, Pharm.D

  Celgene

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 11, 2018
• Study Start: September 10, 2018
• Primary Completion: January 10, 2019
• Study Completion: January 10, 2019
• Last Updated: February 6, 2019

Record last verified: 2019-02

Locations

US (2)