Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)
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|ClinicalTrials.gov Identifier: NCT01536249|
Recruitment Status : Completed
First Posted : February 22, 2012
Last Update Posted : November 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Drug: Dexpramipexole Drug: Cimetidine plus Dexpramipexole||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Study to Assess the Effect of Cimetidine on the Pharmacokinetics of Dexpramipexole (BIIB050) in Healthy Volunteers|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Experimental: Dexpramipexole single dose & 12 Doses Cimetidine
300 mg Dexpramipexole Oral Dose (to be taken in conjunction with multiple doses of Cimetidine at 400 mg per dose)
Drug: Cimetidine plus Dexpramipexole
Multiple Oral Doses
Experimental: Dexpramipexole single Dose
300 mg Dexpramipexole Oral Dose
Single Oral Dose
- Determination of the effect of cimetidine on the PK of dexpramipexole parameters including: AUC: Area under the plasma-concentration time curve over a specified time period; Cmax: Maximum observed plasma concentration and CLr: renal clearance [ Time Frame: pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, and 72 hours after dexpramipexole administration in each dosing period. ]
- PK parameters of dexpramipexole including, but not limited to, half-life when given with or without cimetidine [ Time Frame: pre-dose and at 15, 30, and 45 minutes, and 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, and 72 hours after dexpramipexole administration in each dosing period. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536249
|United States, Kansas|
|Overland Park, Kansas, United States|