Alternate Dosing Regimens of BG00012 in Healthy Volunteers
109HV106
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
1 other identifier
interventional
56
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Feb 2011
Shorter than P25 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2011
CompletedFirst Posted
Study publicly available on registry
January 21, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 18, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2011
CompletedAugust 23, 2023
August 1, 2023
2 months
January 20, 2011
August 22, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
• incidence of treatment emergent AEs
11 days
• incidence of serious AEs (SAEs)
11 days
• clinical laboratory assessments:
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.
11 days
Secondary Outcomes (3)
• incidence, severity, and duration (time of onset until time of resolution) of flushing based on flushing severity measurements.
11 days
• Incidence, severity, duration, and characteristics of GI events
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
11 days
Study Arms (5)
BG00012 plus ASA
EXPERIMENTALBG00012 plus ASA matching placebo
EXPERIMENTALBG00012 Placebo plus ASA
PLACEBO COMPARATORBG00012 Placebo plus ASA matching placebo
EXPERIMENTALBG00012
EXPERIMENTALmodified dose regimen
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (1)
Research Site
Saint Paul, Minnesota, 55114, United States
Related Publications (1)
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.
PMID: 24139424DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2011
First Posted
January 21, 2011
Study Start
February 1, 2011
Primary Completion
March 18, 2011
Study Completion
March 18, 2011
Last Updated
August 23, 2023
Record last verified: 2023-08