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

Phase 1

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: Study Drug; Drug: Active Control; Drug: Placebo

• Registration Number: NCT02201849
• Lead Sponsor: Biogen

Brief Summary

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

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 Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-18
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-28
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-22
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Drug	Study Drug	Oral capsules
Active Control	Active Control	Oral capsules
Placebo	Placebo	Oral capsules

Primary Outcome Measures

Name	Time	Method
Safety and tolerability will be measured by incidence of adverse events	up to 27 days

Secondary Outcome Measures

Name	Time	Method
Maximum plasma concentration (Cmax)	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)	Up to 27 days
Area under the concentration-time curve from time 0 to infinity (AUCinf)	Up to 27 days
Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast)	Up to 27 days

Trial Locations

Locations (1)

Alkermes Investigational Site; 🇺🇸 Austin, Texas, United States