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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BG00012 Dose 2; Drug: BG00012 Dose 1

• Registration Number: NCT01453426
• Lead Sponsor: Biogen

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.

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.

The study will be conducted in male and female Chinese, Japanese, and Caucasian healthy volunteers.

Study Timeline

• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-13
• Study First Posted: 2011-10-17
• Study Start: 2012-01
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-05
• Last Update Submitted: 2013-09-12
• Last Update Posted: 2013-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Japanese Subjects - Dose 2 BG00012	BG00012 Dose 2	-
Chinese Subjects - Dose 1 BG00012	BG00012 Dose 1	-
Chinese Subjects - Dose 2 BG00012	BG00012 Dose 2	-
Japanese Subjects - Dose 1 BG00012	BG00012 Dose 1	-
Caucasian Subjects - Dose 2 BG00012	BG00012 Dose 2	-
Caucasian Subjects - Dose 1 BG00012	BG00012 Dose 1	-

Primary Outcome Measures

Name	Time	Method
Cmax of BG00012	First dose to 24 hours
AUC of BG00012	First dose to 24 hours

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇨🇳 Hong Kong, Hong Kong, China