BG00012 Regional Absorption Study

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924832
• Other study ID #: 109HV111
• Secondary ID: EUDRA CT NO: 201
• Status: Completed
• Phase: Phase 1
• First received: August 1, 2013
• Last updated: February 12, 2015
• Start date: August 2013
• Est. completion date: April 2014

Study information

• Verified date: February 2015
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• dimethyl fumarate
tablet

Locations

Country	Name	City	State
United Kingdom	Research Site	Nottingham

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The maximum observed concentration: Cmax		Up to week 9	No
Primary	The time to reach maximum observed concentration: Tmax		Up to week 9	No
Primary	The area under the plasma concentration versus time curve from time zero to 24 hours		Up to week 9	No
Primary	The area under the plasma concentration versus time curve from time zero to time t (the last sampling time with quantifiable monomethyl fumarate [MMF])		Up to week 9	No
Primary	The area under the plasma concentration versus time curve from time zero to infinity		Up to week 9	No
Primary	The apparent elimination half-life		Up to week 9	No
Primary	The time prior to the first quantifiable monomethyl fumarate (MMF) plasma concentration		Up to week 9	No
Primary	Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 1		Up to week 9	No
Primary	Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 2		Up to week 9	No
Secondary	The number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to week 9	Yes