NCT Number: NCT01453426
Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy Volunteers
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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Notify MeKey information
Conditions
Age range
18 year–55 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1
Primary location
Research Site, Melbourne, Victoria, Australia
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
BG00012 Dose 2
DrugPrimary outcomes
-
AUC of BG00012
Time frame: First dose to 24 hours
-
Cmax of BG00012
Time frame: First dose to 24 hours
Secondary outcomes
-
Number of Adverse Events, as a measure of safety and tolerability
Time frame: 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
Time frame: Subjects will be followed for the duration of the study, an expected 20 days
Sponsors and collaborators
Lead sponsor
Biogen
Industry
Registry information
Official study title
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
Acronym: 109HV108
Important dates
- Study start
- 2012
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Oct 17, 2011
- Registry last updated
- Sep 16, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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