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Completed

NCT Number: NCT00837785

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

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.

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Key information

Conditions

Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BG00012

Drug

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

Primary outcomes

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

    Time frame: 24 Hours

Secondary outcomes

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

    Time frame: 24 Hours

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Feb 5, 2009
Registry last updated
Feb 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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