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

A Pharmacokinetics Profile Determination of BG00012 Standard Formulation and the BG00012 Active Pharmaceutical Ingredient (API) After a Single Oral Dose Administered to Healthy Male Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: BG00012

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: BG00012; BG00012 Standard Formulation	Drug: BG00012; Sequence 1: Oral 240 mg BG00012 Standard Formulation & Following 7 day washout period, 240 mg BG00012 API. Sequence 2: 240 mg BG00012 API & Following 7 day washout period, 240 mg BG00012 Standard Formulation.
Active Comparator: BG00012 API	Drug: BG00012; Sequence 1: Oral 240 mg BG00012 Standard Formulation & Following 7 day washout period, 240 mg BG00012 API. Sequence 2: 240 mg BG00012 API & Following 7 day washout period, 240 mg BG00012 Standard Formulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Biogen
• Investigators: Study Director: Biogen Idec Medical Director, Biogen Idec, Cambridge, MA USA

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: February 12, 2010
• First Submitted That Met QC Criteria: February 16, 2010
• First Posted (Estimate): February 17, 2010

Study Record Updates

• Last Update Posted (Estimate): February 17, 2010
• Last Update Submitted That Met QC Criteria: February 16, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Keywords: Healthy Volunteer
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Dimethyl Fumarate
• Other Study ID Numbers: 109HV105