Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Drug: Dexpramipexole
* Drug: Cimetidine plus Dexpramipexole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who, in the opinion of the Investigator, are healthy as determined by medical history, physical examination, and 12 lead ECG Adult males/females aged 18 to 55 years inclusive Male and female subjects of childbearing potential must practice effective contraception during the study and up to 90 days after their last dose. Exclusion Criteria: History of malignant disease, including solid tumors and hematologic malignancies. History of clinically significant endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major diseases, as determined by the Investigator. Treatment with prescription medication and/or over-the-counter products and herbal-containing and/or alternative health preparations and procedures. Surgery within 90 days prior to check-in.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexpramipexole single dose & 12 Doses Cimetidine<br>300 mg Dexpramipexole Oral Dose (to be taken in conjunction with multiple doses of Cimetidine at 400 mg per dose) | Drug: Cimetidine plus Dexpramipexole<br>* Multiple Oral Doses<br>|
| Experimental: Dexpramipexole single Dose<br>300 mg Dexpramipexole Oral Dose | Drug: Dexpramipexole<br>* Single Oral Dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK parameters of dexpramipexole including, but not limited to, half-life when given with or without cimetidine |  | 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. |