Dexpramipexole and Warfarin Drug Drug Interaction (DDI) Study

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01597310
First received: May 10, 2012
Last updated: July 19, 2012
Last verified: July 2012
  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
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: 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 Biogen Idec:

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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01597310

Locations
United States, Kansas
Research Site
Overland Park, Kansas, United States
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec Medical Director, Biogen Idec, Inc.
ClinicalTrials.gov Identifier: NCT01597310     History of Changes
Other Study ID Numbers: 223HV105
Study First Received: May 10, 2012
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Warfarin
Pramipexol
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 23, 2014