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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

NONE

Study Groups

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BG00012

BG00012 Standard Formulation

Group Type ACTIVE_COMPARATOR

BG00012

Intervention Type DRUG

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.

BG00012 API

Group Type ACTIVE_COMPARATOR

BG00012

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes