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

Study Description
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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.
Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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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


Locations
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United States, Texas
Alkermes Investigational Site
Austin, Texas, United States
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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
Keywords provided by Biogen:
Alkermes
ALKS 8700
Additional relevant MeSH terms:
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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