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

NCT02201849 | Completed Phase 1

• 1 other identifier: ALK8700-001
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Multiple Sclerosis

Keywords

Alkermes; ALKS 8700

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability will be measured by incidence of adverse events

  up to 27 days

Secondary Outcomes (4)

• Maximum plasma concentration (Cmax)

  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

Study Arms (3)

Study Drug

EXPERIMENTAL

Oral capsules

Drug: Study Drug

Active Control

ACTIVE COMPARATOR

Oral capsules

Drug: Active Control

Placebo

PLACEBO COMPARATOR

Oral capsules

Drug: Placebo

Interventions

Study Drug DRUG

Also known as: ALKS 8700 capsules

Study Drug

Active Control DRUG

Also known as: TECFIDERA® capsules

Active Control

Placebo DRUG

Also known as: Placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biogen: lead

Study Sites (1)

Alkermes Investigational Site

Austin, Texas, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Drug Evaluation; Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Development; Investigative Techniques; Evaluation Studies as Topic; Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2014
• First Posted: July 28, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 26, 2019

Record last verified: 2019-11

Locations

US (1)