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

NCT ID: NCT02201849

Last Updated: 2019-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2014-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Study Drug

Oral capsules

Group Type EXPERIMENTAL

Study Drug

Intervention Type DRUG

Active Control

Oral capsules

Group Type ACTIVE_COMPARATOR

Active Control

Intervention Type DRUG

Placebo

Oral capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Study Drug

Intervention Type DRUG

Active Control

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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ALKS 8700 capsules TECFIDERA® capsules Placebo capsules

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Alkermes Investigational Site

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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ALK8700-001

Identifier Type: -

Identifier Source: org_study_id

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