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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02201849
• Date of registration: 18/07/2014
• Prospective Registration: No
• Primary sponsor: Biogen
• Public title: A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults
• Scientific title: A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults
• Date of first enrolment: July 2014
• Target sample size: 104
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02201849
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

United States

Contacts

• Name: Medical Director
• Affiliation: Biogen

Key inclusion & exclusion criteria

Inclusion Criteria:

- Has a body-mass Index (BMI) >/=18.0 and
- 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



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Active Control

Drug: Placebo

Drug: Study Drug

Primary Outcome(s)

Safety and tolerability will be measured by incidence of adverse events [Time Frame: up to 27 days]

Secondary Outcome(s)

Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast) [Time Frame: Up to 27 days]

Maximum plasma concentration (Cmax) [Time Frame: up to 27 days]

Area under the concentration-time curve from time 0 to infinity (AUCinf) [Time Frame: Up to 27 days]

Time to attain Cmax (Tmax) [Time Frame: Up to 27 days]

Secondary ID(s)

ALK8700-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors