Phase 1 Study to Evaluate the PK, Safety, and Tolerability of BG00012 in Chinese, Japanese, and Caucasian Healthy Volunteers (109HV108)

September 12, 2013 updated by: Biogen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

71

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia
        • Research Site
  • China
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chinese Subjects - Dose 1 BG00012
Drug: BG00012 Dose 1
Experimental: Chinese Subjects - Dose 2 BG00012
Drug: BG00012 Dose 2
Experimental: Japanese Subjects - Dose 1 BG00012
Drug: BG00012 Dose 1
Experimental: Japanese Subjects - Dose 2 BG00012
Drug: BG00012 Dose 2
Experimental: Caucasian Subjects - Dose 1 BG00012
Drug: BG00012 Dose 1
Experimental: Caucasian Subjects - Dose 2 BG00012
Drug: BG00012 Dose 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
AUC of BG00012
Time Frame: First dose to 24 hours
First dose to 24 hours
Cmax of BG00012
Time Frame: First dose to 24 hours
First dose to 24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Subjects will be followed for the duration of the study, an expected 20 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

April 1, 2012

Study Registration Dates

First Submitted

October 13, 2011

First Submitted That Met QC Criteria

October 13, 2011

First Posted (Estimate)

October 17, 2011

Study Record Updates

Last Update Posted (Estimate)

September 16, 2013

Last Update Submitted That Met QC Criteria

September 12, 2013

Last Verified

May 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109HV108

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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