Clinical trial NCT03665610: Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Keywords: Pharmacodynamics
Pharmacokinetics
Ozanimod
Safety
Healthy Subjects
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2018-09-11
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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).

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.


Eligibility 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

Primary outcomes:
measure: Adverse events (AEs)
timeFrame: From enrollment up to 75 +/- 10 days after the last dose in the parent study (RPC01-1912, RPC01-1913, or RPC01-1914)
Secondary outcomes:
measure: Pharmacodynamics - absolute lymphocyte count (ALC)
timeFrame: Up to 75 +/- 10 days after the last dose in the parent study (RPC01-1913 or RPC01-1914)
measure: Pharmacodynamics - lymphocyte subsets
timeFrame: Up to 75 +/- 10 days after the last dose in the parent study (RPC01-1913 or RPC01-1914)
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase 1 Clinic
state: Texas
city: San Antonio
country: United States
facility: ICON Early Phase Services, LLC
state: Texas
Study officials:
affiliation: Celgene
name: Jonathan Tran, Pharm.D
role: STUDY_DIRECTOR
References: