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

NCT ID: NCT01453426

Last Updated: 2013-09-16

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.

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

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Melbourne, Victoria, Australia

Site Status

Research Site

Hong Kong, Hong Kong, China

Site Status

Countries

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Australia China

Other Identifiers

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109HV108

Identifier Type: -

Identifier Source: org_study_id