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Alternate Dosing Regimens of BG00012 in Healthy Volunteers (109HV106)

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: NCT01281111
Recruitment Status : Completed
First Posted : January 21, 2011
Last Update Posted : November 18, 2011
Information provided by:

Tracking Information
First Submitted Date  ICMJE January 20, 2011
First Posted Date  ICMJE January 21, 2011
Last Update Posted Date November 18, 2011
Study Start Date  ICMJE February 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 20, 2011)
  • • incidence of treatment emergent AEs [ Time Frame: 11 days ]
  • • incidence of serious AEs (SAEs) [ Time Frame: 11 days ]
  • • clinical laboratory assessments: [ Time Frame: 11 days ]
  • • Concentration versus time data for BG00012 (as measured by monomethyl fumarate (MMF), will be collected for each treatment group. Plasma PK parameters will include AUC, Cmax, time to maximum plasma concentration, half life & lagtime. [ Time Frame: 11 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 20, 2011)
  • • incidence, severity, and duration (time of onset until time of resolution) of flushing based on flushing severity measurements. [ Time Frame: 11 days ]
  • • Incidence, severity, duration, and characteristics of GI events [ Time Frame: 11 days ]
  • • concentrations of PGD2 and/or its metabolites in plasma and/or urine and other prostaglandins, as well as other biomarkers in plasma and/or urine [ Time Frame: 11 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Alternate Dosing Regimens of BG00012 in Healthy Volunteers
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of BG00012 Administered With and Without 325 mg Aspirin in Healthy Adult Volunteers
Brief Summary The purpose of this study is to evaluate the safety, tolerability, and PK of different doses and dosing regimens of BG00012 administered with and without ASA compared to placebo.
Detailed Description Preclinical safety margins for BG00012 allow for a maximum daily dose of 720 mg daily. The study will use a variety of clinical scales, including a flushing scale derived from a validated questionnaire [Norquist 2007], to better understand the safety and tolerability of several doses and dosing regimens of BG00012 up to a total daily dose of 720 mg. The etiology of BG00012-induced flushing will be assessed by collecting relevant biomarker data and the impact of ASA on flushing will be evaluated. Assessments relating to GI symptoms will also be performed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: Dimethyl Fumarate (BG00012)
  • Drug: Aspirin
  • Drug: BG00012 matching placebo
  • Drug: ASA matching placebo
Study Arms  ICMJE
  • Experimental: BG00012 plus ASA
    • Drug: Dimethyl Fumarate (BG00012)
    • Drug: Aspirin
  • Experimental: BG00012 plus ASA matching placebo
    • Drug: Dimethyl Fumarate (BG00012)
    • Drug: ASA matching placebo
  • Placebo Comparator: BG00012 Placebo plus ASA
    • Drug: Aspirin
    • Drug: BG00012 matching placebo
  • Experimental: BG00012 Placebo plus ASA matching placebo
    • Drug: BG00012 matching placebo
    • Drug: ASA matching placebo
  • Experimental: BG00012
    modified dose regimen
    Intervention: Drug: Dimethyl Fumarate (BG00012)
Publications * Sheikh SI, Nestorov I, Russell H, O'Gorman J, Huang R, Milne GL, Scannevin RH, Novas M, Dawson KT. Tolerability and pharmacokinetics of delayed-release dimethyl fumarate administered with and without aspirin in healthy volunteers. Clin Ther. 2013 Oct;35(10):1582-1594.e9. doi: 10.1016/j.clinthera.2013.08.009.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 20, 2011)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
  • Aged 18 to 55 years old, inclusive, at the time of informed consent.
  • Must be in good health, as determined by the Investigator, based on medical history and screening evaluations.
  • Must have a body mass index of 18 to 34 kg/m2, inclusive.
  • Subjects of childbearing potential 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, endocrinologic, GI, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
  • History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
  • Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator within the 3 months prior to Day 1.
  • Diarrhea, constipation, abdominal pain, flushing, or nausea within 28 days prior to Day 1.
  • History of severe allergic or anaphylactic reactions. Additionally, subjects with a history of intolerance to ASA or non-steroidal anti-inflammatory drugs (NSAIDS) must be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01281111
Other Study ID Numbers  ICMJE 109HV106
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen Idec Medical Director, Biogen Idec, Inc
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Biogen
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP