A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults
What it found
We found no results in the registry or in papers.
This trial finished 11 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- Diroximel fumarate
Kelch-like ECH-associated protein 1 inhibitor
Compared with
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
Placebo or sham
- Placebo
What it measured
Main measures
Safety and tolerability will be measured by incidence of adverse events
up to 27 days
Safety
Other measures (4)
Maximum plasma concentration (Cmax)
up to 27 days
How the body handles the medicineTime to attain Cmax (Tmax)
Up to 27 days
How the body handles the medicineArea under the concentration-time curve from 0 to the last quantifiable time interval (AUClast)
Up to 27 days
Area under the concentration-time curve from time 0 to infinity (AUCinf)
Up to 27 days
Who could take part
MS (type not specified) · 18 to 55
Inclusion Criteria: * Has a body-mass Index (BMI) >/=18.0 and \</=32.0 kg/m2 * Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration * Additional criteria may apply Exclusion Criteria: * Is currently pregnant or breastfeeding * Has a lifetime history of menopausal hot flashes * Has a clinically significant medical condition * Has had a clinically significant illness in the 30 days prior to first study drug administration * Has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to study drug administration * Has had any vaccinations in the 4 weeks prior to inpatient admission * Has a lifetime history of diabetes * Additional criteria may apply
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a monomethyl fumerate (MMF) molecule.
Papers
Loading reviews and guidelines…
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History
Started
Jul 2014
Main results due
Dec 2014
Finished
Dec 2014
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