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

An Open-Label, Parallel-Group, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Adult Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01453426

Acronym

109HV108

Enrollment

Registered

2011-10-17

Start date

2012-01-31

Completion date

2012-04-30

Last updated

2013-09-16

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

Conditions

Healthy

Brief summary

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

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.

Interventions

DRUGBG00012 Dose 1

DRUGBG00012 Dose 2

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
AUC of BG00012	First dose to 24 hours
Cmax of BG00012	First dose to 24 hours

Secondary

Measure	Time frame
Number of Adverse Events, as a measure of safety and tolerability	Subjects will be followed for the duration of the study, an expected 20 days
Number of Serious Adverse Events, as a measure of safety and tolerability	Subjects will be followed for the duration of the study, an expected 20 days

Countries

Australia, China

Outcome results

None listed

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