A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02201849 |
Recruitment Status :
Completed
First Posted : July 28, 2014
Last Update Posted : November 26, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Drug: Study Drug Drug: Active Control Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 104 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults |
Study Start Date : | July 2014 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Study Drug
Oral capsules
|
Drug: Study Drug
Other Name: ALKS 8700 capsules |
Active Comparator: Active Control
Oral capsules
|
Drug: Active Control
Other Name: TECFIDERA® capsules |
Placebo Comparator: Placebo
Oral capsules
|
Drug: Placebo
Other Name: Placebo capsules |
- Safety and tolerability will be measured by incidence of adverse events [ Time Frame: up to 27 days ]
- Maximum plasma concentration (Cmax) [ Time Frame: up to 27 days ]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) [ Time Frame: Up to 27 days ]
- Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast) [ Time Frame: Up to 27 days ]
- Area under the concentration-time curve from time 0 to infinity (AUCinf) [ Time Frame: Up to 27 days ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02201849
United States, Texas | |
Alkermes Investigational Site | |
Austin, Texas, United States |
Study Director: | Medical Director | Biogen |
Responsible Party: | Biogen |
ClinicalTrials.gov Identifier: | NCT02201849 |
Other Study ID Numbers: |
ALK8700-001 |
First Posted: | July 28, 2014 Key Record Dates |
Last Update Posted: | November 26, 2019 |
Last Verified: | November 2019 |
Alkermes ALKS 8700 |
Multiple Sclerosis Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases Demyelinating Diseases Autoimmune Diseases |
Immune System Diseases Dimethyl Fumarate Dermatologic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |