Alternate Dosing Regimens of BG00012 in Healthy Volunteers (109HV106)
This study has been completed.
Sponsor:
Biogen Idec
Information provided by:
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01281111
First received: January 20, 2011
Last updated: November 17, 2011
Last verified: November 2011
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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 More Information
No publications provided
| 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 May 19, 2013