Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy Volunteers

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

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-04-30

Brief Summary

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This is an open-label, parallel-group study to evaluate the PK, safety, and tolerability of two different dose regimens of BG00012 over a 24-hour period to adult Chinese, Japanese, and Caucasian healthy volunteers.

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Detailed Description

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The purpose of this healthy volunteer study is to provide pharmacokinetic and safety data for two different dose regimens of BG00012. The study will evaluate BG00012 administered over a 24-hour period.

The study will be conducted in male and female Chinese, Japanese, and Caucasian healthy volunteers.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Chinese Subjects - Dose 1 BG00012

Group Type EXPERIMENTAL

BG00012 Dose 1

Intervention Type DRUG

Chinese Subjects - Dose 2 BG00012

Group Type EXPERIMENTAL

BG00012 Dose 2

Intervention Type DRUG

Japanese Subjects - Dose 1 BG00012

Group Type EXPERIMENTAL

BG00012 Dose 1

Intervention Type DRUG

Japanese Subjects - Dose 2 BG00012

Group Type EXPERIMENTAL

BG00012 Dose 2

Intervention Type DRUG

Caucasian Subjects - Dose 1 BG00012

Group Type EXPERIMENTAL

BG00012 Dose 1

Intervention Type DRUG

Caucasian Subjects - Dose 2 BG00012

Group Type EXPERIMENTAL

BG00012 Dose 2

Intervention Type DRUG

Interventions

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BG00012 Dose 1

Intervention Type DRUG

BG00012 Dose 2

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Must give written informed consent and any authorizations required by local law
* 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.

Exclusion Criteria

* History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the Investigator.
* 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 reactions
* Known history of or positive test result for Human Immunodeficiency Virus (HIV)
* Serious infection (e.g., pneumonia, septicemia) within 2 months prior to Screening.
* Female subjects who are pregnant or currently breastfeeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes