Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS



Status:Completed
Conditions:Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - 55
Updated:4/17/2018
Start Date:June 23, 2016
End Date:October 20, 2017

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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

The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of
RPC1063 in RMS.

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.

Key Inclusion Criteria:

- MS, as diagnosed by the revised 2010 McDonald criteria

- Exhibits a relapsing clinical course consistent with RMS and history of brain MRI
lesions consistent with MS

- Expanded disability status scale (EDSS) score between 0 and 6.0

Key Exclusion Criteria:

- Primary progressive MS

- Clinically relevant cardiovascular conditions or other relevant diseases that could
impact the implementation or interpretation of the trial, or put the patient at risk
We found this trial at
6
sites
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Round Rock, TX
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Akron, OH
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2060 Lakeside Centre Way
Knoxville, Tennessee 37922
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Knoxville, TN
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Long Beach, California 90806
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Long Beach, CA
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Raleigh, North Carolina 27607
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Raleigh, NC
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1500 Owens Street
San Francisco, California 94158
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San Francisco, CA
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