NCT01607034

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Knopp Biosciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Dexpramipexole	150 mg single dose

Timeline

• Start date: 2012-06-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-05-28
• Last updated: 2014-11-25

Locations

1 site across 1 country: United States