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OpenTrials
Completed

NCT Number: NCT02201849

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

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

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Alkermes Investigational Site

Austin, Texas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Study Drug

Drug

Other names: ALKS 8700 capsules

Active Control

Drug

Other names: TECFIDERA® capsules

Placebo

Drug

Other names: Placebo capsules

Primary outcomes

  1. Safety and tolerability will be measured by incidence of adverse events

    Time frame: up to 27 days

Secondary outcomes

  1. 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

  2. Time to attain Cmax (Tmax)

    Time frame: Up to 27 days

  3. Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast)

    Time frame: Up to 27 days

  4. Area under the concentration-time curve from time 0 to infinity (AUCinf)

    Time frame: Up to 27 days

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 28, 2014
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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