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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01607034
First received: May 24, 2012
Last updated: August 16, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Healthy Volunteers
Drug: Dexpramipexole
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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. [ Time Frame: zero to 48 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: zero to 48 hours post-dose ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: June 2012
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence 1 - tablet-fast
150 mg Dexpramipexole (intact tablet) single dose under fasted condition
Drug: Dexpramipexole
150 mg single dose
Experimental: Sequence 2 - tablet-fed
150 mg Dexpramipexole (intact tablet) single dose under fed condition
Drug: Dexpramipexole
150 mg single dose
Experimental: Sequence 3 - water-fast
150 mg Dexpramipexole single dose dispersed in water under fasted condition
Drug: Dexpramipexole
150 mg single dose
Experimental: Sequence 4 - apple-fast
150 mg Dexpramipexole single dose crushed and mixed in applesauce under fasted condition
Drug: Dexpramipexole
150 mg single dose

Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01607034

Locations
United States, Minnesota
Research Site
St. Paul, Minnesota, United States
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec Medical Director, Biogen Idec, Inc.
ClinicalTrials.gov Identifier: NCT01607034     History of Changes
Other Study ID Numbers: 223HV106
Study First Received: May 24, 2012
Last Updated: August 16, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Pramipexole
Anti-Dyskinesia Agents
Antioxidants
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014