Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical Ingredient

Biogen

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: BG00012

Study type

Interventional

Funder types

Industry

Identifiers

NCT01069913

109HV105

Details and patient eligibility

About

The purpose of this study is to measure two different formulations of BG00012 to determine how much of each formulation of BG00012 reaches the blood stream and how long it takes the body to get rid of it, when given as a single dose.

Enrollment

14 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Males 18 to 55 years old, inclusive, at the time of informed consent.
Must weigh between 50 kg and 110 kg, inclusive.
Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive.
All subjects must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
Must be a non-smoker, and no use of chewing tobacco, for at least 6 months prior to Day -1.
Must have a screening physical examination and ECG without any clinically significant abnormality (as determined by the Investigator).

Exclusion criteria

History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
History of severe allergic or anaphylactic reaction.
History of any clinically significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major diseases, as determined by the Investigator.
Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator.
Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.