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

Healthy Clinical Trial

— 109HV108  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453426
• Other study ID #: 109HV108
• Status: Completed
• Phase: Phase 1
• First received: October 13, 2011
• Last updated: September 12, 2013
• Start date: January 2012
• Est. completion date: April 2012

Study information

• Verified date: May 2012
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationHong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BG00012 Dose 1

• BG00012 Dose 2

Locations

Country	Name	City	State
Australia	Research Site	Melbourne	Victoria
China	Research Site	Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Countries where clinical trial is conducted

Australia,  China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC of BG00012		First dose to 24 hours	No
Primary	Cmax of BG00012		First dose to 24 hours	No
Secondary	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	Yes
Secondary	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	Yes