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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: Dexpramipexole

• Registration Number: NCT01607034
• Lead Sponsor: Knopp Biosciences

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.

Detailed Description

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 Timeline

• Study First Submitted: 2012-05-24
• Study First Submitted QC: 2012-05-25
• Study First Posted: 2012-05-28
• Study Start: 2012-06
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-24
• Last Update Posted: 2014-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 4 - apple-fast	Dexpramipexole	150 mg Dexpramipexole single dose crushed and mixed in applesauce under fasted condition
Sequence 2 - tablet-fed	Dexpramipexole	150 mg Dexpramipexole (intact tablet) single dose under fed condition
Sequence 1 - tablet-fast	Dexpramipexole	150 mg Dexpramipexole (intact tablet) single dose under fasted condition
Sequence 3 - water-fast	Dexpramipexole	150 mg Dexpramipexole single dose dispersed in water under fasted condition

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 St. Paul, Minnesota, United States