Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS
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ClinicalTrials.gov Identifier: NCT02797015 |
Recruitment Status :
Completed
First Posted : June 13, 2016
Last Update Posted : March 27, 2018
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Sponsor:
Celgene
Information provided by (Responsible Party):
Celgene
Tracking Information | |||
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First Submitted Date ICMJE | May 26, 2016 | ||
First Posted Date ICMJE | June 13, 2016 | ||
Last Update Posted Date | March 27, 2018 | ||
Actual Study Start Date ICMJE | June 23, 2016 | ||
Actual Primary Completion Date | October 20, 2017 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS | ||
Official Title ICMJE | A Phase I, Multicenter, Randomized, 12-Week, Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics and Pharmacodynamics of RPC 1063 in Patients With Relapsing Multiple Sclerosis | ||
Brief Summary | The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of RPC1063 in RMS. | ||
Detailed Description | The purpose of this study is to characterize the full pharmacokinetic and pharmacodynamics profiles of RPC1063 in patients with relapsing multiple sclerosis (RMS) following multiple-dose administration of the two different dosing regimens that are being evaluated in the Phase 3 RMS studies. | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 1 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Basic Science |
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Condition ICMJE | Multiple Sclerosis | ||
Intervention ICMJE | Drug: RPC1063
Oral capsule daily
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Study Arms ICMJE |
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Publications * | Harris S, Tran JQ, Southworth H, Spencer CM, Cree BAC, Zamvil SS. Effect of the sphingosine-1-phosphate receptor modulator ozanimod on leukocyte subtypes in relapsing MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jul 31;7(5). pii: e839. doi: 10.1212/NXI.0000000000000839. Print 2020 Sep. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
22 | ||
Original Estimated Enrollment ICMJE |
24 | ||
Actual Study Completion Date ICMJE | October 20, 2017 | ||
Actual Primary Completion Date | October 20, 2017 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Key Inclusion Criteria:
Key Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT02797015 | ||
Other Study ID Numbers ICMJE | RPC01-1001 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Celgene | ||
Study Sponsor ICMJE | Celgene | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Celgene | ||
Verification Date | March 2018 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |