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

Primary Purpose

Relapsing Remitting Multiple Sclerosis

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BG00012

About this trial

This is an interventional basic science trial for Relapsing Remitting Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Primary progressive, secondary progressive, or progressive-relapsing multiple sclerosis (PRMS).
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.
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.
Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.
Pregnant or nursing women.

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

240 mg (two 120 mg capsules) twice a day

240 mg (two 120 mg capsules) three times a day

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012

Full Information

NCT ID

NCT00837785

First Posted

February 4, 2009

Last Updated

February 13, 2018

Sponsor

Biogen

1. Study Identification

Unique Protocol Identification Number

NCT00837785

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Completed

Study Start Date

February 28, 2009 (Actual)

Primary Completion Date

October 31, 2009 (Actual)

Study Completion Date

October 31, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biogen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Relapsing Remitting Multiple Sclerosis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

240 mg (two 120 mg capsules) twice a day

Arm Title

Arm Type

Experimental

Arm Description

240 mg (two 120 mg capsules) three times a day

Intervention Type

Drug

Intervention Name(s)

BG00012

Intervention Description

240 mg (two 120 mg capsules) orally three times a day

Intervention Type

Drug

Intervention Name(s)

BG00012

Intervention Description

240 mg (two 120 mg capsules) orally twice a day

Primary Outcome Measure Information:

Title

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

Time Frame

24 Hours

Secondary Outcome Measure Information:

Title

To explore the relationship of differences in baseline demographics and dosing factors in the disposition of BG00012

Time Frame

24 Hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Aged 18 to 55 years old, inclusive, at the time of informed consent. Have a confirmed diagnosis of RRMS according to McDonald criteria #1-4. Be ambulatory. Exclusion Criteria: Primary progressive, secondary progressive, or progressive-relapsing multiple sclerosis (PRMS). 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. 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. Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1. Pregnant or nursing women. Other protocol-defined inclusion/exclusion criteria may apply.

Facility Information:

Facility Name

Research Site

City

Berlin

Country

Germany

12. IPD Sharing Statement

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

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