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

Study Overview
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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.

Official Title
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A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Study Drug
* Drug: Active Control
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Drug<br>Oral capsules | Drug: Study Drug<br> <br> * Other names: ALKS 8700 capsules;|
| Active Comparator: Active Control<br>Oral capsules | Drug: Active Control<br> <br> * Other names: TECFIDERA® capsules;|
| Placebo Comparator: Placebo<br>Oral capsules | Drug: Placebo<br> <br> * Other names: Placebo capsules;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability will be measured by incidence of adverse events |  | up to 27 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) | 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 | up to 27 days | 
| Time to attain Cmax (Tmax) |  | Up to 27 days | 
| Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast) |  | Up to 27 days | 
| Area under the concentration-time curve from time 0 to infinity (AUCinf) |  | Up to 27 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alkermes, ALKS 8700