Status:
COMPLETED
Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy Volunteers
Lead Sponsor:
Biogen
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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 healt...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT01453426
Start Date
January 1 2012
End Date
April 1 2012
Last Update
September 16 2013
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Research Site
Melbourne, Victoria, Australia
2
Research Site
Hong Kong, Hong Kong, China