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

Phase 1

Completed

• Conditions: Relapsing Remitting Multiple Sclerosis
• Interventions: Drug: BG00012

• Registration Number: NCT00837785
• Lead Sponsor: Biogen

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-04
• Study First Submitted QC: 2009-02-04
• Study First Posted: 2009-02-05
• Study Start: 2009-02-28
• Primary Completion: 2009-10-31
• Study Completion: 2009-10-31
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-13
• Last Update Posted: 2018-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	BG00012	240 mg (two 120 mg capsules) twice a day
2	BG00012	240 mg (two 120 mg capsules) three times a day

Primary Outcome Measures

Name	Time	Method
To establish a PK profile of MMF during a 24-hour BG00012 dosing period in subjects with RRMS	24 Hours

Secondary Outcome Measures

Name	Time	Method
To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012	24 Hours

Trial Locations

Locations (1)

Research Site; 🇩🇪 Berlin, Germany