Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02797015
• Other study ID #: RPC01-1001
• Status: Completed
• Phase: Phase 1
• First received: May 26, 2016
• Last updated: March 26, 2018
• Start date: June 23, 2016
• Est. completion date: October 20, 2017

Study information

• Verified date: March 2018
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: October 20, 2017
• Est. primary completion date: October 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• RPC1063
Oral capsule daily

Locations

Country	Name	City	State
United States	Neurology and Neuroscience Associates Inc.	Akron	Ohio
United States	Hope Neurology MS Center	Knoxville	Tennessee
United States	Breastlink Medical Group, Inc.	Long Beach	California
United States	Raleigh Neurology Associates PA	Raleigh	North Carolina
United States	Central Texas Neurology Consultants PA	Round Rock	Texas
United States	Multiple Sclerosis Center at UCSF	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax)	Maximum plasma concentration (Cmax)	24 hours after the last RPC1063 dose on Day 85
Primary	Area under the plasma concentration-time curve (AUC)	Area under the plasma concentration-time curve (AUC)	Approximately 3 months
Secondary	Adverse Events	Number of participants with treatment-emergent adverse events	Up to 28 days after the last RPC1063 dose
Secondary	EDSS (Expanded Disability Status Scale)	Changes from baseline in EDSS	Up to the last RPC1036 dose on Day 85
Secondary	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