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BIIB061

Phase 1

Multiple Sclerosis | Small molecule | Immunology |Biogen Inc.|Last Updated: Sep 7, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment8
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02521545Single-Dose Study of a New Formulation of BIIB061PHASE1 COMPLETED 8Jul 1, 2015Aug 1, 2015Sep 7, 20151 United States
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Study Endpoints
Primary Endpoints
PK parameter - area under the concentration-time curve from time 0 to infinity (AUCinf)
Day 1-4, 6, 10, 14, 21
PK parameter - AUC from time 0 to time of the last measurable concentration (AUClast)
Day 1-4, 6, 10, 14, 21
PK parameter - maximum observed concentration (Cmax)
Day 1-4, 6, 10, 14, 21
Secondary Endpoints
PK parameter - Time to reach maximum observed concentration (Tmax)
Day 1-4, 6, 10, 14, 21
PK parameter - half-life (t1/2)
Day 1-4, 6, 10, 14, 21
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Up to 21 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BIIB061EXPERIMENTALSingle oral dose of 30 mg BIIB061 of the new formulation
Interventions
NameTypeDescription
BIIB061DRUGCapsule
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Eligibility Criteria
Age Range20 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone \[FSH\] levels determined at screening to be in the postmenopausal range) or surgically sterile females. * All male subjects must practice effective contraception dur...

Countries:United States
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