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

Healthy Volunteers Clinical Trial

Official title:

An Open-Label, Randomized, Crossover Study to Assess the Bioavailability of Dexpramipexole Administered in Soft Food and Water, and in Intact Tablet Form in the Fasted and Fed States in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607034
• Other study ID #: 223HV106
• Status: Completed
• Phase: Phase 1
• First received: May 24, 2012
• Last updated: November 24, 2014
• Start date: June 2012
• Est. completion date: July 2012

Study information

• Verified date: November 2014
• Source: Knopp Biosciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Dexpramipexole
150 mg single dose

Locations

Country	Name	City	State
United States	Research Site	St. Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Knopp Biosciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters of dexpramipexole including maximum plasma concentration (Cmax) and the area under the plasma concentration-time curve over time from 0 to infinity (AUC0-inf) of dexpramipexole.		zero to 48 hours post-dose	No
Secondary	Time to the maximum plasma concentration (Tmax), the area under the plasma concentration-time curve over time from 0 to t (AUC0-t) and terminal half-life (t½) of dexpramipexole.		zero to 48 hours post-dose	No