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BG00012 Regional Absorption Study

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.
 
ClinicalTrials.gov Identifier: NCT01924832
Recruitment Status : Completed
First Posted : August 19, 2013
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability profile following the delivery of BG00012 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Drug: dimethyl fumarate Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Study to Investigate the Pharmacokinetics, Safety, and Tolerability of BG00012 (Dimethyl Fumarate) When Delivered to Different Regions of the Gastrointestinal Tract in Healthy Subjects
Study Start Date : August 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BG00012 Part 1
BG00012 120 mg delivered to varying locations of the GI tract
Drug: dimethyl fumarate
tablet
Other Names:
  • DMF
  • Tecfidera
  • BG00012

Experimental: BG00012 Part 2
BG00012 240 mg delivered to varying locations of the GI tract
Drug: dimethyl fumarate
tablet
Other Names:
  • DMF
  • Tecfidera
  • BG00012




Primary Outcome Measures :
  1. The maximum observed concentration: Cmax [ Time Frame: Up to week 9 ]
  2. The time to reach maximum observed concentration: Tmax [ Time Frame: Up to week 9 ]
  3. The area under the plasma concentration versus time curve from time zero to 24 hours [ Time Frame: Up to week 9 ]
  4. The area under the plasma concentration versus time curve from time zero to time t (the last sampling time with quantifiable monomethyl fumarate [MMF]) [ Time Frame: Up to week 9 ]
  5. The area under the plasma concentration versus time curve from time zero to infinity [ Time Frame: Up to week 9 ]
  6. The apparent elimination half-life [ Time Frame: Up to week 9 ]
  7. The time prior to the first quantifiable monomethyl fumarate (MMF) plasma concentration [ Time Frame: Up to week 9 ]
  8. Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 1 [ Time Frame: Up to week 9 ]
  9. Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 2 [ Time Frame: Up to week 9 ]

Secondary Outcome Measures :
  1. The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to week 9 ]


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

Key Inclusion Criteria:

  • Healthy males or non-pregnant, non-lactating healthy females.
  • Body mass index (BMI) of 18 through 35 kg/m2.
  • Subjects of childbearing potential (including males) must practice effective contraception during the study and be willing and able to continue contraception for 90 days after their last dose of study treatment

Key Exclusion Criteria:

  • History of or positive test result at Screening for human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
  • Serious infection (e.g., pneumonia, septicemia) within the 3 months prior to first dose.
  • Vaccinations within 4 weeks prior to first dose.
  • History of drug or alcohol abuse (as defined by the Investigator) within the previous 2 years, or regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint of beer, 25 mL of 40% spirit or a 125 mL glass of wine).
  • History of clinically significant gastrointestinal (GI) disease as determined by the Investigator (including Crohn's Disease, Ulcerative Colitis, confirmed diagnosis of active Irritable Bowel Syndrome).
  • 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.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.


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 ClinicalTrials.gov identifier (NCT number): NCT01924832


Locations
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United Kingdom
Research Site
Nottingham, United Kingdom, NJ116JS
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01924832    
Other Study ID Numbers: 109HV111
EUDRA CT NO: 2013-002048-96
First Posted: August 19, 2013    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015
Additional relevant MeSH terms:
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Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs