Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS

Phase 1

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: RPC1063

• Registration Number: NCT02797015
• Lead Sponsor: Celgene

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 Timeline

• Study First Submitted: 2016-05-26
• Study First Submitted QC: 2016-06-07
• Study First Posted: 2016-06-13
• Study Start: 2016-06-23
• Primary Completion: 2017-10-20
• Study Completion: 2017-10-20
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.5 mg RPC1063	RPC1063	0.5 mg RPC1063 oral capsule daily
1 mg RPC1063	RPC1063	1 mg RPC1063 oral capsule daily

Primary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax)	24 hours after the last RPC1063 dose on Day 85	Maximum plasma concentration (Cmax)
Area under the plasma concentration-time curve (AUC)	Approximately 3 months	Area under the plasma concentration-time curve (AUC)

Secondary Outcome Measures

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

Trial Locations

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

Central Texas Neurology Consultants PA; 🇺🇸 Round Rock, Texas, United States

Neurology and Neuroscience Associates Inc.; 🇺🇸 Akron, Ohio, United States

Hope Neurology MS Center; 🇺🇸 Knoxville, Tennessee, United States