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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BG00012

• Registration Number: NCT01069913
• Lead Sponsor: Biogen

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Primary Completion: 2009-10
• Study Completion: 2010-01
• Status Verified: 2010-02
• Study First Submitted: 2010-02-12
• Study First Submitted QC: 2010-02-16
• Last Update Submitted: 2010-02-16
• Study First Posted: 2010-02-17
• Last Update Posted: 2010-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

Inclusion Criteria

1. Males 18 to 55 years old, inclusive, at the time of informed consent.
2. Must weigh between 50 kg and 110 kg, inclusive.
3. Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive.
4. 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.
5. Must be a non-smoker, and no use of chewing tobacco, for at least 6 months prior to Day -1.
6. Must have a screening physical examination and ECG without any clinically significant abnormality (as determined by the Investigator).

Exclusion Criteria

1. History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
2. History of severe allergic or anaphylactic reaction.
3. 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.
4. Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator.
5. Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
BG00012	BG00012	BG00012 Standard Formulation
BG00012 API	BG00012	BG00012 API

Primary Outcome Measures

Name	Time	Method
PK profiles of the current BG00012 standard formulation and the BG00012 API formulation in healthy volunteers. Primary PK parameter will be the area under the plasma concentration curve	4 days post dosing period 2

Secondary Outcome Measures

Name	Time	Method
To assess the safety and tolerability of the current oral BG00012 standard formulation and the encapsulated oral BG00012 API	4 days after dosing period 2