Study in Healthy Volunteers of the Bioavailability of Dexpramipexole Tablets and Food Effects
An Open-Label, Randomized, Crossover Study to Assess the Bioavailability of Dexpramipexole Administered in Soft Food and Water, and in Intact Tablet Form in the Fasted and Fed States in Healthy Volunteers
1 other identifier
interventional
24
1 country
1
Brief Summary
To assess the bioavailability of dexpramipexole when mixed in soft food and water, and in intact tablet form in the fasted and fed states in healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy-volunteers
Started Jun 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
First Submitted
Initial submission to the registry
May 24, 2012
CompletedFirst Posted
Study publicly available on registry
May 28, 2012
CompletedStudy Start
First participant enrolled
June 1, 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
1 month
May 24, 2012
November 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
PK parameters of dexpramipexole including maximum plasma concentration (Cmax) and the area under the plasma concentration-time curve over time from 0 to infinity (AUC0-inf) of dexpramipexole.
zero to 48 hours post-dose
Secondary Outcomes (1)
Time to the maximum plasma concentration (Tmax), the area under the plasma concentration-time curve over time from 0 to t (AUC0-t) and terminal half-life (t½) of dexpramipexole.
zero to 48 hours post-dose
Study Arms (4)
Sequence 1 - tablet-fast
EXPERIMENTAL150 mg Dexpramipexole (intact tablet) single dose under fasted condition
Sequence 2 - tablet-fed
EXPERIMENTAL150 mg Dexpramipexole (intact tablet) single dose under fed condition
Sequence 3 - water-fast
EXPERIMENTAL150 mg Dexpramipexole single dose dispersed in water under fasted condition
Sequence 4 - apple-fast
EXPERIMENTAL150 mg Dexpramipexole single dose crushed and mixed in applesauce under fasted condition
Interventions
150 mg single dose
Eligibility Criteria
You may qualify if:
- Subjects who, in the opinion of the Investigator, are healthy as determined by pre-study medical history, physical examination and 12-lead ECG.
- Adult males/females aged 18 to 55 years inclusive.
- Male subjects and female subjects of childbearing potential must practice effective contraception during the study and 90 days after their last dose of study drug.
You may not qualify if:
- History of malignant disease, including solid tumors and hematologic malignancies.
- History of any clinically significant endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases, as determined by the Investigator.
- Surgery within 90 days prior to check in.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Research Site
Saint Paul, Minnesota, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 24, 2012
First Posted
May 28, 2012
Study Start
June 1, 2012
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
November 25, 2014
Record last verified: 2014-11