Dexpramipexole and Warfarin Drug Drug Interaction (DDI) Study
This study has been completed.
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01597310
First received: May 10, 2012
Last updated: July 19, 2012
Last verified: July 2012
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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 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 May 19, 2013