Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01420458
Recruitment Status : Completed
First Posted : August 19, 2011
Last Update Posted : November 4, 2011
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Brief Summary:
This is an open-label, single-center, 2 period crossover, PK profile study. Each subject will be randomized to 1 of 2 treatment sequences. Both treatment sequences will be enrolled concurrently.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: Experimental Phase 1

Detailed Description:
This is a study of healthy volunteers to demonstrate bioequivalence of two formulations of BG-00012 given in capsule form..

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Randomized, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of Two Formulations of BG00012.
Study Start Date : August 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: Experimental
    Bioequivalence of two drug formulations

Primary Outcome Measures :
  1. Area under the plasma concentration curve as a measure of PK. [ Time Frame: Participants will be followed during the duration of the study, 4 days. Samples taken at -15mins, 30 mins, 60 mins, 90 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 7 hrs, 8 hrs, 10 hrs, 12 hrs ]

Secondary Outcome Measures :
  1. The number of AEs in participants as a measure of safety and tolerability. [ Time Frame: Participants will be followed during the time of study - an estimated four days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Must give written and informed consent and any authorizations required by local law.
  • Males and females 18 - 55 years old inclusive at time of consent.
  • Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

Exclusion Criteria:

  • History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
  • Known history of or positive test result for Human Immunodeficiency Virus (HIV)
  • History of severe allergic or anaphylactic reactions.
  • History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic,metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric and renal or other major disease, as determined by the Investigator.
  • Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator, and any screening values for alanine aminotransferase (ALT) aspartate aminotransferase (AST) total bilirubin, or creatinine above the upper limit of normal, or an out of normal range screening value for white blood cells (WBC).
  • Current enrollment in any other drug, biologic, or device study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01420458

United States, Minnesota
Research Site
Minneapolis, Minnesota, United States
Sponsors and Collaborators

Responsible Party: Medical Director, Biogen Idec Identifier: NCT01420458     History of Changes
Other Study ID Numbers: 109HV107
First Posted: August 19, 2011    Key Record Dates
Last Update Posted: November 4, 2011
Last Verified: November 2011

Keywords provided by Biogen:

Additional relevant MeSH terms:
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs