CLINICAL TRIALS PROFILE FOR MONOMETHYL FUMARATE
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All Clinical Trials for MONOMETHYL FUMARATE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00837785 ↗ | A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS | Completed | Biogen | Phase 1 | 2009-02-28 | To establish a pharmacokinetic (PK) profile of BG00012, as measured by its primary metabolite, monomethyl fumarate (MMF), during a 24-hour dosing period in subjects with relapsing-remitting multiple sclerosis (RRMS), with a variety of baseline demographic characteristics. |
| NCT01924832 ↗ | BG00012 Regional Absorption Study | Completed | Biogen | Phase 1 | 2013-08-01 | The primary objective of this study is to evaluate the pharmacokinetics (PK) profile of monomethyl fumarate (MMF) following delivery of BG00012 (dimethyl fumarate, DMF) 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability profile following the delivery of BG00012 120 mg (Part 1) and BG00012 240 mg (Part 2) to varying regions within the GI tract in healthy volunteers. |
| NCT02201849 ↗ | A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults | Completed | Alkermes, Inc. | Phase 1 | 2014-07-01 | This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a monomethyl fumerate (MMF) molecule. |
| NCT02201849 ↗ | A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults | Completed | Biogen | Phase 1 | 2014-07-01 | This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a monomethyl fumerate (MMF) molecule. |
| NCT02683863 ↗ | Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers | Completed | Biogen | Phase 4 | 2015-08-01 | The purpose of this study is to explore whether DMF (Dimethyl Fumarate) or MMF (monomethyl fumarate) its main bioactive metabolite, is capable of entering the central nervous system in SPMS patients that are being treated with Tecfidera®. PK samples (pharmacokinetics - or the amount of study drug in blood) will be tested to compare with PK samples, the amount of study drug, in spinal fluid (CSF). |
| NCT02683863 ↗ | Pharmacokinetics of DMF and the Effects of DMF on Exploratory Biomarkers | Completed | Multiple Sclerosis Center of Northeastern New York | Phase 4 | 2015-08-01 | The purpose of this study is to explore whether DMF (Dimethyl Fumarate) or MMF (monomethyl fumarate) its main bioactive metabolite, is capable of entering the central nervous system in SPMS patients that are being treated with Tecfidera®. PK samples (pharmacokinetics - or the amount of study drug in blood) will be tested to compare with PK samples, the amount of study drug, in spinal fluid (CSF). |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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