Dexpramipexole and Warfarin Drug Drug Interaction (DDI) Study
An Open-Label Study to Assess the Effect of Dexpramipexole (BIIB050) on the Pharmacokinetics of Warfarin in Healthy Volunteers
1 other identifier
interventional
15
1 country
1
Brief Summary
This study will assess the effect of dexpramipexole on the pharmacokinetics (PK) of the CYP2C9 probe substrate warfarin in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 healthy-volunteers
Started May 2012
Shorter than P25 for phase_1 healthy-volunteers
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 10, 2012
CompletedFirst Posted
Study publicly available on registry
May 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedNovember 25, 2014
November 1, 2014
2 months
May 10, 2012
November 24, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
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
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
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
Study Arms (2)
Warfarin
EXPERIMENTAL25 mg Warfarin, Treatment Period 1 \& Treatment Period 2
Dexpramipexole
EXPERIMENTAL150 mg BID Treatment Period 2
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Site
Overland Park, Kansas, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2012
First Posted
May 14, 2012
Study Start
May 1, 2012
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
November 25, 2014
Record last verified: 2014-11