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Dexpramipexole and Warfarin Drug Drug Interaction (DDI) Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01597310
First Posted: May 14, 2012
Last Update Posted: November 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Knopp Biosciences
  Purpose
This study will assess the effect of dexpramipexole on the pharmacokinetics (PK) of the CYP2C9 probe substrate warfarin in healthy volunteers.

Condition Intervention Phase
Healthy Volunteers Drug: Warfarin Drug: Dexpramipexole Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: An Open-Label Study to Assess the Effect of Dexpramipexole (BIIB050) on the Pharmacokinetics of Warfarin in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Knopp Biosciences:

Primary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: May 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Warfarin
25 mg Warfarin, Treatment Period 1 & Treatment Period 2
Drug: Warfarin
single doses at specified time periods
Experimental: Dexpramipexole
150 mg BID Treatment Period 2
Drug: Dexpramipexole
multiple doses

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597310


Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
Knopp Biosciences
  More Information

Responsible Party: Knopp Biosciences
ClinicalTrials.gov Identifier: NCT01597310     History of Changes
Other Study ID Numbers: 223HV105
First Submitted: May 10, 2012
First Posted: May 14, 2012
Last Update Posted: November 25, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Warfarin
Pramipexole
Anticoagulants
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents