This study will assess the effect of dexpramipexole on the pharmacokinetics (PK) of the
CYP2C9 probe substrate warfarin in healthy volunteers.
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Locations near you
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Full eligibility criteria for NCT01597310
Ages eligible for Study
18 Years to 55 Years
Genders eligible for Study
Accepts Healthy Volunteers
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.
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.
All locations for NCT01597310
United States (1)
Overland Park, Kansas, United States
View full eligibility
Tris trial is registered with FDA with number: NCT01597310. The sponsor of the trial is Knopp Biosciences and it is looking for 15 volunteers for the current phase.
Official trial title: An Open-Label Study to Assess the Effect of Dexpramipexole (BIIB050) on the Pharmacokinetics of Warfarin in Healthy Volunteers
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