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Study in Healthy Volunteers of the Bioavailability of Dexpramipexole Tablets and Food Effects

NCT ID: NCT01607034

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

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2012-07-31

Brief Summary

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To assess the bioavailability of dexpramipexole when mixed in soft food and water, and in intact tablet form in the fasted and fed states in healthy volunteers.

Detailed Description

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The effect of food on dexpramipexole bioavailability following administration of the proposed commercial formulation (capsule-shaped tablet) at the anticipated therapeutic dose (150 mg twice daily) has not been studied. Therefore, this study has been designed to evaluate the effect of a standard high-fat, high-calorie meal on dexpramipexole bioavailability following administration of a single 150 mg dose in healthy volunteers, consistent with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) recommendations.

Additionally, patients with ALS can have difficulty swallowing tablets, necessitating alternative methods of administration for the drug. Therefore, this study has also been designed to evaluate the bioavailability of dexpramipexole mixed with water or crushed in soft food (applesauce).

Conditions

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Healthy Volunteers

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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Sequence 1 - tablet-fast

150 mg Dexpramipexole (intact tablet) single dose under fasted condition

Group Type EXPERIMENTAL

Dexpramipexole

Intervention Type DRUG

150 mg single dose

Sequence 2 - tablet-fed

150 mg Dexpramipexole (intact tablet) single dose under fed condition

Group Type EXPERIMENTAL

Dexpramipexole

Intervention Type DRUG

150 mg single dose

Sequence 3 - water-fast

150 mg Dexpramipexole single dose dispersed in water under fasted condition

Group Type EXPERIMENTAL

Dexpramipexole

Intervention Type DRUG

150 mg single dose

Sequence 4 - apple-fast

150 mg Dexpramipexole single dose crushed and mixed in applesauce under fasted condition

Group Type EXPERIMENTAL

Dexpramipexole

Intervention Type DRUG

150 mg single dose

Interventions

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Dexpramipexole

150 mg single dose

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects who, in the opinion of the Investigator, are healthy as determined by pre-study medical history, physical examination and 12-lead ECG.
* Adult males/females aged 18 to 55 years inclusive.
* Male subjects and female subjects of childbearing potential must practice effective contraception during the study and 90 days after their last dose of study drug.

Exclusion Criteria

* History of malignant disease, including solid tumors and hematologic malignancies.
* History of any clinically significant endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases, as determined by the Investigator.
* 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

Saint Paul, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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223HV106

Identifier Type: -

Identifier Source: org_study_id