Alternate Dosing Regimens of BG00012 in Healthy Volunteers (109HV106)

This study has been completed.
Sponsor:
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01281111
First received: January 20, 2011
Last updated: November 17, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to evaluate the safety, tolerability, and PK of different doses and dosing regimens of BG00012 administered with and without ASA compared to placebo.


Condition Intervention Phase
Healthy
Drug: Dimethyl Fumarate (BG00012)
Drug: Aspirin
Drug: BG00012 matching placebo
Drug: ASA matching placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Tolerability, and Pharmacokinetics of BG00012 Administered With and Without 325 mg Aspirin in Healthy Adult Volunteers

Resource links provided by NLM:


Further study details as provided by Biogen Idec:

Primary Outcome Measures:
  • • incidence of treatment emergent AEs [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
  • • incidence of serious AEs (SAEs) [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
  • • clinical laboratory assessments: [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
  • • Concentration versus time data for BG00012 (as measured by monomethyl fumarate (MMF), will be collected for each treatment group. Plasma PK parameters will include AUC, Cmax, time to maximum plasma concentration, half life & lagtime. [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • • incidence, severity, and duration (time of onset until time of resolution) of flushing based on flushing severity measurements. [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
  • • Incidence, severity, duration, and characteristics of GI events [ Time Frame: 11 days ] [ Designated as safety issue: Yes ]
  • • concentrations of PGD2 and/or its metabolites in plasma and/or urine and other prostaglandins, as well as other biomarkers in plasma and/or urine [ Time Frame: 11 days ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: February 2011
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BG00012 plus ASA Drug: Dimethyl Fumarate (BG00012) Drug: Aspirin
Experimental: BG00012 plus ASA matching placebo Drug: Dimethyl Fumarate (BG00012) Drug: ASA matching placebo
Placebo Comparator: BG00012 Placebo plus ASA Drug: Aspirin Drug: BG00012 matching placebo
Experimental: BG00012 Placebo plus ASA matching placebo Drug: BG00012 matching placebo Drug: ASA matching placebo
Experimental: BG00012
modified dose regimen
Drug: Dimethyl Fumarate (BG00012)

Detailed Description:

Preclinical safety margins for BG00012 allow for a maximum daily dose of 720 mg daily. The study will use a variety of clinical scales, including a flushing scale derived from a validated questionnaire [Norquist 2007], to better understand the safety and tolerability of several doses and dosing regimens of BG00012 up to a total daily dose of 720 mg. The etiology of BG00012-induced flushing will be assessed by collecting relevant biomarker data and the impact of ASA on flushing will be evaluated. Assessments relating to GI symptoms will also be performed.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
  • Aged 18 to 55 years old, inclusive, at the time of informed consent.
  • Must be in good health, as determined by the Investigator, based on medical history and screening evaluations.
  • Must have a body mass index of 18 to 34 kg/m2, inclusive.
  • Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.

Exclusion Criteria:

  • History of any clinically significant cardiac, endocrinologic, GI, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
  • History of malignant disease, including solid tumors and hematologic malignancies (except basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
  • Serious infection (e.g., pneumonia, septicemia) as determined by the Investigator within the 3 months prior to Day 1.
  • Diarrhea, constipation, abdominal pain, flushing, or nausea within 28 days prior to Day 1.
  • History of severe allergic or anaphylactic reactions. Additionally, subjects with a history of intolerance to ASA or non-steroidal anti-inflammatory drugs (NSAIDS) must be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01281111

Locations
United States, Minnesota
Research Site
St. Paul, Minnesota, United States, 55114
Sponsors and Collaborators
Biogen Idec
  More Information

No publications provided by Biogen Idec

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Biogen Idec Medical Director, Biogen Idec, Inc
ClinicalTrials.gov Identifier: NCT01281111     History of Changes
Other Study ID Numbers: 109HV106
Study First Received: January 20, 2011
Last Updated: November 17, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Aspirin
Dimethyl fumarate
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 22, 2014