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Dexpramipexole and Cimetidine Drug Drug Interaction (DDI)

NCT ID: NCT01536249

Last Updated: 2014-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-04-30

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.

Conditions

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Amyotrophic Lateral Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

Cimetidine plus Dexpramipexole

Intervention Type DRUG

Multiple Oral Doses

Dexpramipexole single Dose

300 mg Dexpramipexole Oral Dose

Group Type EXPERIMENTAL

Dexpramipexole

Intervention Type DRUG

Single Oral Dose

Interventions

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Dexpramipexole

Single Oral Dose

Intervention Type DRUG

Cimetidine plus Dexpramipexole

Multiple Oral Doses

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Knopp Biosciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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223HV104

Identifier Type: -

Identifier Source: org_study_id