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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a monomethyl fumerate (MMF) molecule.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alkermes, Inc.; Biogen
• Treatments: Dimethyl Fumarate

Criteria

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