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

• ClinicalTrials.gov Identifier: NCT01281111
• Recruitment Status: Completed
• First Posted: January 21, 2011
• Last Update Posted: November 18, 2011
• Sponsor: Biogen
• Information provided by: Biogen

Tracking Information

• First Submitted Date: January 20, 2011
• First Posted Date: January 21, 2011
• Last Update Posted Date: November 18, 2011
• Study Start Date: February 2011
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 20, 2011)

• • incidence of treatment emergent AEs [ Time Frame: 11 days ]
• • incidence of serious AEs (SAEs) [ Time Frame: 11 days ]
• • clinical laboratory assessments: [ Time Frame: 11 days ]
• • 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 ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 20, 2011)

• • incidence, severity, and duration (time of onset until time of resolution) of flushing based on flushing severity measurements. [ Time Frame: 11 days ]
• • Incidence, severity, duration, and characteristics of GI events [ Time Frame: 11 days ]
• • 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Alternate Dosing Regimens of BG00012 in Healthy Volunteers
• 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
• Brief Summary: 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.
• 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.
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Factorial Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Healthy

Intervention

• Drug: Dimethyl Fumarate (BG00012)
• Drug: Aspirin
• Drug: BG00012 matching placebo
• Drug: ASA matching placebo

Study Arms

• Experimental: BG00012 plus ASA
  Interventions:

  • Drug: Dimethyl Fumarate (BG00012)
  • Drug: Aspirin
• Experimental: BG00012 plus ASA matching placebo
  Interventions:

  • Drug: Dimethyl Fumarate (BG00012)
  • Drug: ASA matching placebo
• Placebo Comparator: BG00012 Placebo plus ASA
  Interventions:

  • Drug: Aspirin
  • Drug: BG00012 matching placebo
• Experimental: BG00012 Placebo plus ASA matching placebo
  Interventions:

  • Drug: BG00012 matching placebo
  • Drug: ASA matching placebo
• Experimental: BG00012
  modified dose regimen
  Intervention: Drug: Dimethyl Fumarate (BG00012)

• Publications *: Sheikh SI, Nestorov I, Russell H, O'Gorman J, Huang R, Milne GL, Scannevin RH, Novas M, Dawson KT. Tolerability and pharmacokinetics of delayed-release dimethyl fumarate administered with and without aspirin in healthy volunteers. Clin Ther. 2013 Oct;35(10):1582-1594.e9. doi: 10.1016/j.clinthera.2013.08.009.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 20, 2011): 56
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: March 2011
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01281111
• Other Study ID Numbers: 109HV106
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Biogen Idec Medical Director, Biogen Idec, Inc
• Study Sponsor: Biogen
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Biogen
• Verification Date: November 2011