BG00012 Regional Absorption Study

NCT01924832 | Completed Phase 1

• 2 other identifiers: 109HV111EUDRA CT NO: 2013-002048-96
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (9)

• The maximum observed concentration: Cmax

  Up to week 9

• The time to reach maximum observed concentration: Tmax

  Up to week 9

• The area under the plasma concentration versus time curve from time zero to 24 hours

  Up to week 9

• 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

• The area under the plasma concentration versus time curve from time zero to infinity

  Up to week 9

• The apparent elimination half-life

  Up to week 9

• The time prior to the first quantifiable monomethyl fumarate (MMF) plasma concentration

  Up to week 9

• Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 1

  Up to week 9

• Area under the plasma concentration versus time curve (AUC) ratio of test regimens compared with reference for Part 2

  Up to week 9

Secondary Outcomes (1)

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

  Up to week 9

Study Arms (2)

BG00012 Part 1

EXPERIMENTAL

BG00012 120 mg delivered to varying locations of the GI tract

Drug: dimethyl fumarate

BG00012 Part 2

EXPERIMENTAL

BG00012 240 mg delivered to varying locations of the GI tract

Drug: dimethyl fumarate

Interventions

dimethyl fumarate DRUG

tablet

Also known as: DMF, Tecfidera, BG00012

BG00012 Part 1; BG00012 Part 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Research Site

Nottingham, NJ116JS, United Kingdom

Location

MeSH Terms

Interventions

Dimethyl Fumarate

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 19, 2013
• Study Start: August 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: February 16, 2015

Record last verified: 2015-02

Locations

GB (1)