Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS

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

Detailed Description
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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.

Official Title
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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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: RPC1063


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 mg RPC1063<br>1 mg RPC1063 oral capsule daily | Drug: RPC1063<br>* Oral capsule daily<br>|
| Experimental: 0.5 mg RPC1063<br>0.5 mg RPC1063 oral capsule daily | Drug: RPC1063<br>* Oral capsule daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) | Maximum plasma concentration (Cmax) | 24 hours after the last RPC1063 dose on Day 85 | 
| Area under the plasma concentration-time curve (AUC) | Area under the plasma concentration-time curve (AUC) | Approximately 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of participants with treatment-emergent adverse events | Up to 28 days after the last RPC1063 dose | 
| EDSS (Expanded Disability Status Scale) | Changes from baseline in EDSS | Up to the last RPC1036 dose on Day 85 | 
| Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count | Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count (absolute and %) | Up to 28 days after the last RPC1063 dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MS, RMS, Multiple Sclerosis, Relapsing Multiple Sclerosis