Back to resultsA Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Study Drug
Active Control
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Alkermes, ALKS 8700
Eligibility Criteria
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
Sites / Locations
- Alkermes Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Study Drug
Active Control
Placebo
Arm Description
Oral capsules
Oral capsules
Oral capsules
Outcomes
Primary Outcome Measures
Safety and tolerability will be measured by incidence of adverse events
Secondary Outcome Measures
Maximum plasma concentration (Cmax)
Concentrations will be measured predose and at 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose
Time to attain Cmax (Tmax)
Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast)
Area under the concentration-time curve from time 0 to infinity (AUCinf)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02201849
Brief Title
A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults
Official Title
A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 record.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Alkermes, ALKS 8700
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Drug
Arm Type
Experimental
Arm Description
Oral capsules
Arm Title
Active Control
Arm Type
Active Comparator
Arm Description
Oral capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Oral capsules
Intervention Type
Drug
Intervention Name(s)
Study Drug
Other Intervention Name(s)
ALKS 8700 capsules
Intervention Type
Drug
Intervention Name(s)
Active Control
Other Intervention Name(s)
TECFIDERA® capsules
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo capsules
Primary Outcome Measure Information:
Title
Safety and tolerability will be measured by incidence of adverse events
Time Frame
up to 27 days
Secondary Outcome Measure Information:
Title
Maximum plasma concentration (Cmax)
Description
Concentrations will be measured predose and at 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose
Time Frame
up to 27 days
Title
Time to attain Cmax (Tmax)
Time Frame
Up to 27 days
Title
Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast)
Time Frame
Up to 27 days
Title
Area under the concentration-time curve from time 0 to infinity (AUCinf)
Time Frame
Up to 27 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Alkermes Investigational Site
City
Austin
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults
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