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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02797015

Enrollment

Registered

2016-06-13

Start date

2016-06-23

Completion date

2017-10-20

Last updated

2018-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

MS, RMS, Multiple Sclerosis, Relapsing Multiple Sclerosis

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.

Interventions

DRUGRPC1063

Oral capsule daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 %)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026