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

Knopp Biosciences24 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

DexpramipexoleDRUG

150 mg single dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Research Site

Saint Paul, Minnesota, United States

Outcomes

Primary Outcomes

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.

Time frame: zero to 48 hours post-dose

Secondary Outcomes

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.

Time frame: zero to 48 hours post-dose

Data from ClinicalTrials.gov

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