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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alkermes, Inc.
ClinicalTrials.gov Identifier:
NCT02201849
First received: July 18, 2014
Last updated: January 12, 2015
Last verified: January 2015
  Purpose
This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a monomethyl fumerate (MMF) molecule.

Condition Intervention Phase
Multiple Sclerosis Drug: Study Drug Drug: Active Control Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:


Further study details as provided by Alkermes, Inc.:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 104
Study Start Date: July 2014
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02201849

Locations
United States, Texas
Alkermes Investigational Site
Austin, Texas, United States
Sponsors and Collaborators
Alkermes, Inc.
Investigators
Study Director: Richard Leigh-Pemberton, MD Alkermes, Inc.
  More Information

Responsible Party: Alkermes, Inc.
ClinicalTrials.gov Identifier: NCT02201849     History of Changes
Other Study ID Numbers: ALK8700-001
Study First Received: July 18, 2014
Last Updated: January 12, 2015

Keywords provided by Alkermes, Inc.:
Alkermes
ALKS 8700

Additional relevant MeSH terms:
Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2017