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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT01607034

Run by

Knopp Biosciences

People needed

24

Starts

2012-06-01

Expected to finish

2012-07-01

Last updated by the study team

2014-11-25

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Research Site — Saint Paul, Minnesota, United States

Full record on ClinicalTrials.gov

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