A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults

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.

This study record was previously posted/updated by Alkermes, Inc. As of 29 Oct 2019, the sponsorship of the trial was transferred to Biogen along with responsibility for subsequent updates to the record.

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