Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS

Celgene22 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis

Interventions

RPC1063DRUG

Oral capsule daily

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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

Locations (6)

Breastlink Medical Group, Inc.

Long Beach, California, United States

Multiple Sclerosis Center at UCSF

San Francisco, California, United States

Raleigh Neurology Associates PA

Raleigh, North Carolina, United States

Neurology and Neuroscience Associates Inc.

Akron, Ohio, United States

Outcomes

Primary Outcomes

Maximum plasma concentration (Cmax)

Time frame: 24 hours after the last RPC1063 dose on Day 85

Area under the plasma concentration-time curve (AUC)

Time frame: Approximately 3 months

Secondary Outcomes

Adverse Events

Number of participants with treatment-emergent adverse events

Time frame: Up to 28 days after the last RPC1063 dose

EDSS (Expanded Disability Status Scale)

Changes from baseline in EDSS

Time frame: 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 %)

Time frame: Up to 28 days after the last RPC1063 dose

Data from ClinicalTrials.gov

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