Alternate Dosing Regimens of BG00012 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Dimethyl Fumarate (BG00012); Drug: ASA matching placebo; Drug: Aspirin; Drug: BG00012 matching placebo

• Registration Number: NCT01281111
• Lead Sponsor: Biogen

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 Timeline

• Study First Submitted: 2011-01-20
• Study First Submitted QC: 2011-01-20
• Study First Posted: 2011-01-21
• Study Start: 2011-02-01
• Primary Completion: 2011-03-18
• Study Completion: 2011-03-18
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
BG00012 plus ASA matching placebo	Dimethyl Fumarate (BG00012)	-
BG00012 plus ASA matching placebo	ASA matching placebo	-
BG00012 plus ASA	Dimethyl Fumarate (BG00012)	-
BG00012 plus ASA	Aspirin	-
BG00012 Placebo plus ASA	Aspirin	-
BG00012 Placebo plus ASA	BG00012 matching placebo	-
BG00012 Placebo plus ASA matching placebo	BG00012 matching placebo	-
BG00012 Placebo plus ASA matching placebo	ASA matching placebo	-
BG00012	Dimethyl Fumarate (BG00012)	modified dose regimen

Primary Outcome Measures

Name	Time	Method
• incidence of treatment emergent AEs	11 days
• incidence of serious AEs (SAEs)	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
• clinical laboratory assessments:	11 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Saint Paul, Minnesota, United States