Dexpramipexole and Warfarin Drug Drug Interaction (DDI) Study

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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

Key facts

Study ID

NCT01597310

Run by

Knopp Biosciences

People needed

15

Starts

2012-05-01

Expected to finish

2012-07-01

Last updated by the study team

2014-11-25

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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