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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01069913

Enrollment

Registered

2010-02-17

Start date

2009-10-31

Completion date

2010-01-31

Last updated

2010-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy Volunteer

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.

Interventions

DRUGBG00012

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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026