NCT01536249

Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)

An Open-Label Study to Assess the Effect of Cimetidine on the Pharmacokinetics of Dexpramipexole (BIIB050) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Knopp Biosciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This study will assess the effect of cimetidine on the pharmacokinetics (PK) of dexpramipexole in healthy volunteer and evaluate the safety and tolerability of dexpramipexole when given with or without cimetidine. Additionally, this study will explore the influence of genetic variation on the PK of dexpramipexole when given with or without cimetidine.

Detailed description

This is a single-center, open-label, randomized, two-period, crossover study in approximately 14 healthy subjects. The goals of this study are as follows: To assess the effect of cimetidine on the pharmacokinetics (PK) of dexpramipexole in healthy volunteers. To evaluate the safety and tolerability of dexpramipexole when given with or without cimetidine. To explore the influence of genetic variation on the PK of dexpramipexole when given with or without cimetidine.

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	Dexpramipexole	Single Oral Dose
DRUG	Cimetidine plus Dexpramipexole	Multiple Oral Doses

Timeline

• Start date: 2012-03-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2012-02-22
• Last updated: 2014-11-25

Locations

1 site across 1 country: United States