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

Relapsing Remitting Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837785
• Other study ID #: 109MS101
• Status: Completed
• Phase: Phase 1
• First received: February 4, 2009
• Last updated: February 13, 2018
• Start date: February 28, 2009
• Est. completion date: October 31, 2009

Study information

• Verified date: February 2018
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 31, 2009
• Est. primary completion date: October 31, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing Remitting Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• BG00012
240 mg (two 120 mg capsules) orally three times a day
• BG00012
240 mg (two 120 mg capsules) orally twice a day

Locations

Country	Name	City	State
Germany	Research Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS		24 Hours
Secondary	To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012		24 Hours