A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Neurology, Multiple Sclerosis |
| Therapuetic Areas: | Neurology, Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 2/7/2015 |
| Start Date: | July 2014 |
| End Date: | December 2014 |
| Contact: | Tiffany Reyes |
| Phone: | 512-747-4972 |
A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults
This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a
monomethyl fumerate (MMF) molecule.
monomethyl fumerate (MMF) molecule.
Inclusion Criteria:
- Has a body-mass Index (BMI) >/=18.0 and
- 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
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