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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Experimental

Study type: Interventional

Funder types: Industry

Identifiers

NCT01420458

109HV107

Details and patient eligibility

About

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.

Full description

This is a study of healthy volunteers to demonstrate bioequivalence of two formulations of BG-00012 given in capsule form..

Enrollment: 80 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.