A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS

February 13, 2018 updated by: Biogen

A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With Multiple Sclerosis

To establish a pharmacokinetic (PK) profile of BG00012, as measured by its primary metabolite, monomethyl fumarate (MMF), during a 24-hour dosing period in subjects with relapsing-remitting multiple sclerosis (RRMS), with a variety of baseline demographic characteristics.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged 18 to 55 years old, inclusive, at the time of informed consent.
  2. Have a confirmed diagnosis of RRMS according to McDonald criteria #1-4.
  3. Be ambulatory.

Exclusion Criteria:

  1. Primary progressive, secondary progressive, or progressive-relapsing multiple sclerosis (PRMS).
  2. History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic (other than MS), dermatologic, psychiatric, renal, oncologic, anaphylaxis or other major diseases, as determined by the Investigator.
  3. Current enrollment in any other drug, biologic, or device study or treatment with another investigational drug within 6 months or 5 half-lives of the investigational product, whichever time period is longer.
  4. Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.
  5. Pregnant or nursing women.

Other protocol-defined inclusion/exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
240 mg (two 120 mg capsules) twice a day
Drug: BG00012
240 mg (two 120 mg capsules) orally three times a day
Drug: BG00012
240 mg (two 120 mg capsules) orally twice a day
Experimental: 2
240 mg (two 120 mg capsules) three times a day
Drug: BG00012
240 mg (two 120 mg capsules) orally three times a day
Drug: BG00012
240 mg (two 120 mg capsules) orally twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS
Time Frame: 24 Hours
24 Hours

Secondary Outcome Measures

Outcome Measure
Time Frame
To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012
Time Frame: 24 Hours
24 Hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2009

Primary Completion (Actual)

October 31, 2009

Study Completion (Actual)

October 31, 2009

Study Registration Dates

First Submitted

February 4, 2009

First Submitted That Met QC Criteria

February 4, 2009

First Posted (Estimate)

February 5, 2009

Study Record Updates

Last Update Posted (Actual)

February 15, 2018

Last Update Submitted That Met QC Criteria

February 13, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109MS101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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