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Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02797015
Recruitment Status : Completed
First Posted : June 13, 2016
Last Update Posted : March 27, 2018
Sponsor:
Information provided by (Responsible Party):
Celgene

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: RPC1063 Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : June 23, 2016
Actual Primary Completion Date : October 20, 2017
Actual Study Completion Date : October 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1 mg RPC1063
1 mg RPC1063 oral capsule daily
Drug: RPC1063
Oral capsule daily

Experimental: 0.5 mg RPC1063
0.5 mg RPC1063 oral capsule daily
Drug: RPC1063
Oral capsule daily




Primary Outcome Measures :
  1. Maximum plasma concentration (Cmax) [ Time Frame: 24 hours after the last RPC1063 dose on Day 85 ]
    Maximum plasma concentration (Cmax)

  2. Area under the plasma concentration-time curve (AUC) [ Time Frame: Approximately 3 months ]
    Area under the plasma concentration-time curve (AUC)


Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: Up to 28 days after the last RPC1063 dose ]
    Number of participants with treatment-emergent adverse events

  2. EDSS (Expanded Disability Status Scale) [ Time Frame: Up to the last RPC1036 dose on Day 85 ]
    Changes from baseline in EDSS

  3. Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count [ Time Frame: Up to 28 days after the last RPC1063 dose ]
    Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count (absolute and %)



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02797015


Locations
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United States, California
Breastlink Medical Group, Inc.
Long Beach, California, United States, 90806
Multiple Sclerosis Center at UCSF
San Francisco, California, United States, 94158
United States, North Carolina
Raleigh Neurology Associates PA
Raleigh, North Carolina, United States, 27607
United States, Ohio
Neurology and Neuroscience Associates Inc.
Akron, Ohio, United States, 44320
United States, Tennessee
Hope Neurology MS Center
Knoxville, Tennessee, United States, 37922
United States, Texas
Central Texas Neurology Consultants PA
Round Rock, Texas, United States, 78681
Sponsors and Collaborators
Celgene

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT02797015     History of Changes
Other Study ID Numbers: RPC01-1001
First Posted: June 13, 2016    Key Record Dates
Last Update Posted: March 27, 2018
Last Verified: March 2018

Keywords provided by Celgene:
MS
RMS
Multiple Sclerosis
Relapsing Multiple Sclerosis

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases