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BIIB074 Treatment A

Phase 1

Trigeminal Neuralgia (TN) | Small molecule | Neurology |Biogen Inc.|Last Updated: Feb 27, 2017

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
RandomizedCONTROLLED
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02951221New Formulation and Food Effect Study of BIIB074PHASE1 COMPLETED 28 — — Dec 1, 2016Feb 1, 2017Feb 27, 20171 United States
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Study Endpoints
Primary Endpoints
PK of BIIB074 DCF to RCF as assessed by maximum observed concentration (Cmax)
Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF to RCF as assessed by area under the concentration-time curve (AUC) from time 0 to time of the last measurable concentration (AUClast)
Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF to RCF as assessed by AUC from time 0 to infinity (AUC∞)
Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF as assessed by Cmax
Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF as assessed by AUClast
Day 1, 2, 3, 8, 9, 10
PK of BIIB074 DCF as assessed by AUC∞
Day 1, 2, 3, 8, 9, 10
Secondary Endpoints
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Up to Day 18
Number of participants with clinically significant laboratory assessment abnormalities
Up to Day 10
Number of participants with clinically significant vital sign abnormalities
Up to Day 10
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALTreatment sub groups A and B
Cohort 2EXPERIMENTALTreatment sub groups C and D
Interventions
NameTypeDescription
BIIB074 Treatment ADRUGLower dose RCF fasted
BIIB074 Treatment BDRUGLower dose DCF fasted
BIIB074 Treatment CDRUGHigher dose DCF fasted
BIIB074 Treatment DDRUGHigher dose DCF fed
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Key Inclusion Criteria: * Must have a body mass index between 18 and 30 kg/m2, inclusive. * Must be in good health as determined by the Investigator, based on medical history and screening evaluations. * Ability to consume and tolerate the entire high-fat breakfast within a 30-minute timeframe. Ke...

Countries:United States
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