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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
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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.

Condition or disease Intervention/treatment Phase
Healthy Drug: Dimethyl Fumarate (BG00012) Drug: Aspirin Drug: BG00012 matching placebo Drug: ASA matching placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : February 2011
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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
Drug: Dimethyl Fumarate (BG00012)

Primary Outcome Measures :
  1. • incidence of treatment emergent AEs [ Time Frame: 11 days ]
  2. • incidence of serious AEs (SAEs) [ Time Frame: 11 days ]
  3. • clinical laboratory assessments: [ Time Frame: 11 days ]
  4. • 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 ]

Secondary Outcome Measures :
  1. • incidence, severity, and duration (time of onset until time of resolution) of flushing based on flushing severity measurements. [ Time Frame: 11 days ]
  2. • Incidence, severity, duration, and characteristics of GI events [ Time Frame: 11 days ]
  3. • 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 ]

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:

  • 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.

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): NCT01281111

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United States, Minnesota
Research Site
St. Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Biogen Idec Medical Director, Biogen Idec, Inc Identifier: NCT01281111    
Other Study ID Numbers: 109HV106
First Posted: January 21, 2011    Key Record Dates
Last Update Posted: November 18, 2011
Last Verified: November 2011
Additional relevant MeSH terms:
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Dimethyl Fumarate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors