Try the modernized beta website. Learn more about the modernization effort.
Working… Menu

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

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. Identifier: NCT02201849
Recruitment Status : Completed
First Posted : July 28, 2014
Last Update Posted : November 26, 2019
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Drug: Study Drug Drug: Active Control Drug: Placebo Phase 1

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.

Layout table for study information
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

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Safety and tolerability will be measured by incidence of adverse events [ Time Frame: up to 27 days ]

Secondary Outcome Measures :
  1. 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

  2. Time to attain Cmax (Tmax) [ Time Frame: Up to 27 days ]
  3. Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast) [ Time Frame: Up to 27 days ]
  4. Area under the concentration-time curve from time 0 to infinity (AUCinf) [ Time Frame: Up to 27 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT02201849

Layout table for location information
United States, Texas
Alkermes Investigational Site
Austin, Texas, United States
Sponsors and Collaborators
Layout table for investigator information
Study Director: Medical Director Biogen
Layout table for additonal information
Responsible Party: Biogen 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
Keywords provided by Biogen:
ALKS 8700
Additional relevant MeSH terms:
Layout table for MeSH terms
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