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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02201849
• Other study ID #: ALK8700-001
• Status: Completed
• Phase: Phase 1
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: November 2019
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis

Intervention

Drug:
• Study Drug

• Active Control

• Placebo

Locations

Country	Name	City	State
United States	Alkermes Investigational Site	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability will be measured by incidence of adverse events		up to 27 days
Secondary	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
Secondary	Time to attain Cmax (Tmax)		Up to 27 days
Secondary	Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast)		Up to 27 days
Secondary	Area under the concentration-time curve from time 0 to infinity (AUCinf)		Up to 27 days