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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Knopp Biosciences
• Treatments: Pramipexole

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.