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NCT03665610 · ClinicalTrials.gov registry record
Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites
A clinical trial, sponsored by Celgene.
- Completed
- Registry status
- 212
- Enrollment target
NCT03665610 is a clinical trial that has completed, run by Celgene. The registered enrollment target is 212 participants.
The verdict
NCT03665610 has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- 212 participants
- Enrollment target
Study 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.
Interventions
- DRUG ozanimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 212 participants |
| Start Date | 2018-09-10 |
| Est. Completion | 2019-01-10 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03665610
The ClinicalTrials.gov registry entry for NCT03665610 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 212 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ozanimod is the first listed.
NCT03665610 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03665610 about?
NCT03665610 is a clinical study titled "Extension Study to Further Evaluate the Safety, Pharmacodynamics and Pharmacokinetics of Ozanimod and Active Metabolites". 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 co...
What is the current status of trial NCT03665610?
This trial is currently completed. The enrollment target is 212 participants. The study started on 2018-09-10. Estimated completion is 2019-01-10.
What interventions are being tested in trial NCT03665610?
The interventions under investigation include: ozanimod (DRUG).
Who is sponsoring clinical trial NCT03665610?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
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