Status:
COMPLETED
A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a monomethyl fumerate (MMF) molecule.
Detailed Description
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 reco...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT02201849
Start Date
July 1 2014
End Date
December 1 2014
Last Update
November 26 2019
Active Locations (1)
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1
Alkermes Investigational Site
Austin, Texas, United States