Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled concurrently.

Key facts

Study ID: NCT01420458
Run by: Biogen
People needed: 80
Starts: 2011-08-01
Expected to finish: 2011-09-01
Last updated by the study team: 2011-11-04

Who can join

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

You may qualify if…

Must give written and informed consent and any authorizations required by local law.
Males and females 18 - 55 years old inclusive at time of consent.
Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

You may not qualify if…

History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
Known history of or positive test result for Human Immunodeficiency Virus (HIV)
History of severe allergic or anaphylactic reactions.
History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic,metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric and renal or other major disease, as determined by the Investigator.
Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator, and any screening values for alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin, or creatinine above the upper limit of normal, or an out of normal range screening value for white blood cells (WBC).
Current enrollment in any other drug, biologic, or device study.

Where it is running

Research Site — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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