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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01453426




Registration number
NCT01453426
Ethics application status
Date submitted
13/10/2011
Date registered
17/10/2011
Date last updated
16/09/2013

Titles & IDs
Public title
Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
109HV108
Universal Trial Number (UTN)
Trial acronym
109HV108
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BG00012 Dose 1
Treatment: Drugs - BG00012 Dose 2

Experimental: Chinese Subjects - Dose 1 BG00012 -

Experimental: Chinese Subjects - Dose 2 BG00012 -

Experimental: Japanese Subjects - Dose 1 BG00012 -

Experimental: Japanese Subjects - Dose 2 BG00012 -

Experimental: Caucasian Subjects - Dose 1 BG00012 -

Experimental: Caucasian Subjects - Dose 2 BG00012 -


Treatment: Drugs: BG00012 Dose 1


Treatment: Drugs: BG00012 Dose 2
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
AUC of BG00012
Timepoint [1] 0 0
First dose to 24 hours
Primary outcome [2] 0 0
Cmax of BG00012
Timepoint [2] 0 0
First dose to 24 hours
Secondary outcome [1] 0 0
Number of Adverse Events, as a measure of safety and tolerability
Timepoint [1] 0 0
Subjects will be followed for the duration of the study, an expected 20 days
Secondary outcome [2] 0 0
Number of Serious Adverse Events, as a measure of safety and tolerability
Timepoint [2] 0 0
Subjects will be followed for the duration of the study, an expected 20 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2012
Sample size
Target
Accrual to date
Final
71
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Research Site - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Hong Kong

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Biogen
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT01453426
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries