Study in Healthy Volunteers of the Bioavailability of Dexpramipexole Tablets and Food Effects

Study Overview
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Brief Summary
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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.

Detailed Description
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The effect of food on dexpramipexole bioavailability following administration of the proposed commercial formulation (capsule-shaped tablet) at the anticipated therapeutic dose (150 mg twice daily) has not been studied. Therefore, this study has been designed to evaluate the effect of a standard high-fat, high-calorie meal on dexpramipexole bioavailability following administration of a single 150 mg dose in healthy volunteers, consistent with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) recommendations. Additionally, patients with ALS can have difficulty swallowing tablets, necessitating alternative methods of administration for the drug. Therefore, this study has also been designed to evaluate the bioavailability of dexpramipexole mixed with water or crushed in soft food (applesauce).

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: Dexpramipexole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1 - tablet-fast<br>150 mg Dexpramipexole (intact tablet) single dose under fasted condition | Drug: Dexpramipexole<br>* 150 mg single dose<br>|
| Experimental: Sequence 2 - tablet-fed<br>150 mg Dexpramipexole (intact tablet) single dose under fed condition | Drug: Dexpramipexole<br>* 150 mg single dose<br>|
| Experimental: Sequence 3 - water-fast<br>150 mg Dexpramipexole single dose dispersed in water under fasted condition | Drug: Dexpramipexole<br>* 150 mg single dose<br>|
| Experimental: Sequence 4 - apple-fast<br>150 mg Dexpramipexole single dose crushed and mixed in applesauce under fasted condition | Drug: Dexpramipexole<br>* 150 mg single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |