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Completed

NCT Number: NCT02797015

Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Breastlink Medical Group, Inc., Long Beach, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RPC1063

Drug

Oral capsule daily

Primary outcomes

  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 outcomes

  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 %)

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 13, 2016
Registry last updated
Mar 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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