Dexpramipexole and Warfarin Drug Drug Interaction (DDI) Study

Knopp Biosciences15 enrolled

Overview

This study will assess the effect of dexpramipexole on the pharmacokinetics (PK) of the CYP2C9 probe substrate warfarin in healthy volunteers.

This is a single center open label study to assess the effect of Dexpramipexole on the PK of Warfarin in Healthy Volunteers. The goals of this study are as follows: to assess the effect of dexpramipexole on the pharmacodynamics (PD) of warfarin, to assess the safety and tolerability of dexpramipexole when administered alone, and with warfarin, and to assess the PK of dexpramipexole when administered alone; to explore the influence of genetic variation on the PK and international normalized ratio (INR) of warfarin when administered alone, and with dexpramipexole; and to explore the influence of genetic variation on the PK of dexpramipexole when administered alone.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

WarfarinDRUG

single doses at specified time periods

DexpramipexoleDRUG

multiple doses

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who, in the opinion of the investigator, are healthy as determined by medical history, physical examination, and 12 Lead ECG. * Adult males/females aged 18 to 55 years inclusive. * Male and female subjects of childbearing age must practice effective contraception during the study and up to 90 days after their last dose of study drug. Exclusion Criteria: * History of malignant disease, including solid tumors and hematologic malignancies. * Clinically significant current active infection or serious infection. * History of gastrointestinal bleeding, peptic ulcer disease, hemorrhoids or epistaxis. * Personal or family history of any bleeding disorder, and/or coagulation profile results outside of normal limits. * Known allergy or hypersensitivity to warfarin.

Locations (1)

Research Site

Overland Park, Kansas, United States

Outcomes

Primary Outcomes

Determination of the effect of dexpramipexole on the pharmacokinetics (PK) parameters of the CYP2C9 probe substrate warfarin including: AUC: area under the plasma-concentration time curve over a specified time period and Cmax: Maximum observed plasma c

Time frame: pre-dose and at 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 and 144 hours after warfarin administration in each dosing period

PK parameters of dexpramipexole including but not limited to AUC: area under the plasma-concentration time curve over a specified time period and Cmax: Maximum observed plasma concentration

Time frame: pre-dose and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8 and 12 hours after administration of the morning dexpramipexole dose on Day 1 and Day 12 of Period 2

Data from ClinicalTrials.gov

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