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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: ASA matching placebo; Drug: Aspirin; Drug: BG00012 matching placebo; Drug: Dimethyl Fumarate (BG00012)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01281111

109HV106

Details and patient eligibility

About

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

Full 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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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56 participants in 5 patient groups, including a placebo group

BG00012 plus ASA

Experimental group

Treatment:

Drug: Aspirin

Drug: Dimethyl Fumarate (BG00012)

BG00012 plus ASA matching placebo

Experimental group

Treatment:

Drug: ASA matching placebo

Drug: Dimethyl Fumarate (BG00012)

BG00012 Placebo plus ASA

Placebo Comparator group

Treatment:

Drug: BG00012 matching placebo

Drug: Aspirin

BG00012 Placebo plus ASA matching placebo

Experimental group

Treatment:

Drug: BG00012 matching placebo

Drug: ASA matching placebo

BG00012

Experimental group

Description:

modified dose regimen

Treatment:

Drug: Dimethyl Fumarate (BG00012)