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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01453426
First received: October 13, 2011
Last updated: September 12, 2013
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: BG00012 Dose 1
Drug: BG00012 Dose 2
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • AUC of BG00012 [ Time Frame: First dose to 24 hours ] [ Designated as safety issue: No ]
  • Cmax of BG00012 [ Time Frame: First dose to 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 71
Study Start Date: January 2012
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01453426

Locations
Australia, Victoria
Research Site
Melbourne, Victoria, Australia
China, Hong Kong
Research Site
Hong Kong, Hong Kong, China
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Biogen Idec
ClinicalTrials.gov Identifier: NCT01453426     History of Changes
Other Study ID Numbers: 109HV108
Study First Received: October 13, 2011
Last Updated: September 12, 2013
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Hong Kong: Department of Health

Additional relevant MeSH terms:
Dimethyl fumarate
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on October 01, 2014