Recent Updates
Recently added Catalysts

Study Drug

Phase 1

Multiple Sclerosis | Small molecule | Neurology |Biogen Inc.|Trials Updated: Nov 26, 2019

Study Drug development status

Highest phase Phase 1
Registered trials 2 across 2 sponsors since Jan 2011

Study Drug target and mechanism

ModalitySmall molecule

Also known as ALKS 8700 capsules

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment104

FDA Designations

No designations recorded

Study Drug clinical trials

Study Drug · 1 trial · 1 indication

Phase 1 1
NCT02201849A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy AdultsMultiple Sclerosis
COMPLETED104 Analytics
PHASE1COMPLETED
A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults
Multiple SclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability will be measured by incidence of adverse events
up to 27 days

Secondary Endpoints

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
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Study DrugEXPERIMENTALOral capsules
Active ControlACTIVE_COMPARATOROral capsules
PlaceboPLACEBO_COMPARATOROral capsules

Interventions

NameTypeDescription
Study DrugDRUG -
Active ControlDRUG -
PlaceboDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 brea...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Study Drug

What is Study Drug?

Study Drug is an investigational small molecule developed by Biogen Inc. for multiple sclerosis, a neurological condition. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. It is not described as approved, so it remains in clinical development.

What is Study Drug used for in Multiple Sclerosis?

Study Drug is being developed for multiple sclerosis, a neurological disease. The completed Phase 1 study enrolled healthy adult volunteers rather than patients with multiple sclerosis, so the program is at an early stage of clinical development. No approved use has been established.

Who makes Study Drug?

Biogen Inc., which trades under the ticker BIIB, is the developer of Study Drug. The company sponsored the Phase 1 trial of the asset in multiple sclerosis. Biogen is the named developer associated with this program.

What phase is Study Drug in?

Study Drug is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are listed. Because the program is at this early stage, Study Drug is investigational and has not been established as an approved therapy for multiple sclerosis.

What clinical trials is Study Drug in?

Study Drug has been evaluated in one completed Phase 1 trial, NCT02201849, titled A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults. The trial enrolled 104 participants in the United States, was randomized, double blind, and placebo controlled, and used healthy volunteers aged 18 years and older.

Is Study Drug the same as ALKS 8700?

Yes. Study Drug is also known as ALKS 8700, a monomethyl fumarate (MMF) molecule. The Phase 1 trial NCT02201849 was conducted under the ALKS 8700 name in healthy adults. Searches for either name refer to the same Biogen multiple sclerosis asset.