Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-23

Study Completion Date

2017-10-20

Brief Summary

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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1 mg RPC1063

1 mg RPC1063 oral capsule daily

Group Type EXPERIMENTAL

RPC1063

Intervention Type DRUG

Oral capsule daily

0.5 mg RPC1063

0.5 mg RPC1063 oral capsule daily

Group Type EXPERIMENTAL

RPC1063

Intervention Type DRUG

Oral capsule daily

Interventions

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RPC1063

Oral capsule daily

Intervention Type DRUG

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No