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

Biogen

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis

Treatments: Drug: Active Control; Drug: Study Drug; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02201849

ALK8700-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 3 patient groups, including a placebo group

Study Drug

Experimental group

Description:

Oral capsules

Treatment:

Drug: Study Drug

Active Control

Active Comparator group

Description:

Oral capsules

Treatment:

Drug: Active Control

Placebo

Placebo Comparator group

Description:

Oral capsules

Treatment:

Drug: Placebo