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Completed

NCT Number: NCT01924832

BG00012 Regional Absorption Study

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Nottingham, NJ116JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dimethyl fumarate

Drug

tablet

Other names: DMF, Tecfidera, BG00012

Primary outcomes

  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 outcomes

  1. The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Up to week 9

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 19, 2013
Registry last updated
Feb 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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