Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy Volunteers
109HV108
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
1 other identifier
interventional
71
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Jan 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2011
CompletedFirst Posted
Study publicly available on registry
October 17, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedSeptember 16, 2013
May 1, 2012
3 months
October 13, 2011
September 12, 2013
Conditions
Outcome Measures
Primary Outcomes (2)
AUC of BG00012
First dose to 24 hours
Cmax of BG00012
First dose to 24 hours
Secondary Outcomes (2)
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
Study Arms (6)
Chinese Subjects - Dose 1 BG00012
EXPERIMENTALChinese Subjects - Dose 2 BG00012
EXPERIMENTALJapanese Subjects - Dose 1 BG00012
EXPERIMENTALJapanese Subjects - Dose 2 BG00012
EXPERIMENTALCaucasian Subjects - Dose 1 BG00012
EXPERIMENTALCaucasian Subjects - Dose 2 BG00012
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (2)
Research Site
Melbourne, Victoria, Australia
Research Site
Hong Kong, Hong Kong, China
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 13, 2011
First Posted
October 17, 2011
Study Start
January 1, 2012
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
September 16, 2013
Record last verified: 2012-05