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

History of Changes

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: 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

Resource links provided by NLM:

Genetics Home Reference related topics: multiple sclerosis

U.S. FDA Resources

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 September 19, 2017

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