Clinical trial NCT01924832: BG00012 Regional Absorption Study
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2013-08-19
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The maximum observed concentration: Cmax
timeFrame: Up to week 9
measure: The time to reach maximum observed concentration: Tmax
timeFrame: Up to week 9
measure: The area under the plasma concentration versus time curve from time zero to 24 hours
timeFrame: Up to week 9
measure: The area under the plasma concentration versus time curve from time zero to time t (the last sampling time with quantifiable monomethyl fumarate [MMF])
timeFrame: Up to week 9
measure: The area under the plasma concentration versus time curve from time zero to infinity
timeFrame: Up to week 9
measure: The apparent elimination half-life
timeFrame: Up to week 9
measure: The time prior to the first quantifiable monomethyl fumarate (MMF) plasma concentration
timeFrame: Up to week 9
measure: Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 1
timeFrame: Up to week 9
measure: Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 2
timeFrame: Up to week 9
Secondary outcomes:
measure: The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to week 9
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: