Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)
NCT01536249 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2014-11-25
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.
Conditions
Interventions
- DRUG
-
Dexpramipexole
Single Oral Dose
- DRUG
-
Cimetidine plus Dexpramipexole
Multiple Oral Doses
Sponsors & Collaborators
-
Knopp Biosciences
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-03-31
- Primary Completion
- 2012-04-30
- Completion
- 2012-04-30
Countries
- United States
Study Locations
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