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

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01420458
First received: August 11, 2011
Last updated: November 3, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Healthy Volunteers
 Drug: Experimental
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Randomized, Two-Period Crossover Study in Healthy Volunteers to Establish the Bioequivalence of Two Formulations of BG00012.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: August 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Experimental
    Bioequivalence of two drug formulations
Detailed Description:

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

  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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420458

Locations
United States, Minnesota
Research Site
Minneapolis, Minnesota, United States
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided

Responsible Party: Medical Director, Biogen Idec
ClinicalTrials.gov Identifier: NCT01420458     History of Changes
Other Study ID Numbers: 109HV107
Study First Received: August 11, 2011
Last Updated: November 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Biogen Idec:
bioequivalence

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 May 16, 2013