Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS

Celgene

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis

Treatments: Drug: RPC1063

Study type: Interventional

Funder types: Industry

Identifiers

NCT02797015

RPC01-1001

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

1 mg RPC1063

Experimental group

Description:

1 mg RPC1063 oral capsule daily

Treatment:

Drug: RPC1063

0.5 mg RPC1063

Experimental group

Description:

0.5 mg RPC1063 oral capsule daily

Treatment:

Drug: RPC1063