Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS
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
1 other identifier
interventional
22
1 country
6
Brief Summary
The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of RPC1063 in RMS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 multiple-sclerosis
Started Jun 2016
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 26, 2016
CompletedFirst Posted
Study publicly available on registry
June 13, 2016
CompletedStudy Start
First participant enrolled
June 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2017
CompletedMarch 27, 2018
March 1, 2018
1.3 years
May 26, 2016
March 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Maximum plasma concentration (Cmax)
Maximum plasma concentration (Cmax)
24 hours after the last RPC1063 dose on Day 85
Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration-time curve (AUC)
Approximately 3 months
Secondary Outcomes (3)
Adverse Events
Up to 28 days after the last RPC1063 dose
EDSS (Expanded Disability Status Scale)
Up to the last RPC1036 dose on Day 85
Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count
Up to 28 days after the last RPC1063 dose
Study Arms (2)
1 mg RPC1063
EXPERIMENTAL1 mg RPC1063 oral capsule daily
0.5 mg RPC1063
EXPERIMENTAL0.5 mg RPC1063 oral capsule daily
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celgenelead
Study Sites (6)
Breastlink Medical Group, Inc.
Long Beach, California, 90806, United States
Multiple Sclerosis Center at UCSF
San Francisco, California, 94158, United States
Raleigh Neurology Associates PA
Raleigh, North Carolina, 27607, United States
Neurology and Neuroscience Associates Inc.
Akron, Ohio, 44320, United States
Hope Neurology MS Center
Knoxville, Tennessee, 37922, United States
Central Texas Neurology Consultants PA
Round Rock, Texas, 78681, United States
Related Publications (1)
Harris S, Tran JQ, Southworth H, Spencer CM, Cree BAC, Zamvil SS. Effect of the sphingosine-1-phosphate receptor modulator ozanimod on leukocyte subtypes in relapsing MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jul 31;7(5):e839. doi: 10.1212/NXI.0000000000000839. Print 2020 Sep.
PMID: 32737072DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 26, 2016
First Posted
June 13, 2016
Study Start
June 23, 2016
Primary Completion
October 20, 2017
Study Completion
October 20, 2017
Last Updated
March 27, 2018
Record last verified: 2018-03