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Test product

Phase 1

Healthy Volunteers | Small molecule | Other |Biogen Inc.|Last Updated: May 31, 2013

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01632449Study in Healthy Volunteers to Establish the Bioequivalence of Two Different Manufacturers.PHASE1 COMPLETED 80 — — Jul 1, 2012Sep 1, 2012May 31, 20131 United States
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Study Endpoints
Primary Endpoints
PK - Area under the plasma concentration curve.
Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours
Peak plasma concentration as a measure of PK.
Participants will be followed during the duration of the study, 4 days. Thirteen samples taken over the course of approximately 12 hours
Secondary Endpoints
The number of AEs in participants as a measure of safety and tolerability.
Participants will be followed during the study, 4 days.
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
Treatment Arms
ArmTypeDescription
1EXPERIMENTALTest product
2EXPERIMENTALReference product
Interventions
NameTypeDescription
Test productDRUGDimethyl Fumarate (BG00012)
Reference productDRUGDimethyl Fumarate (BG00012)
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Must give written and informed consent and any authorizations required by local law. * Males and females 18 - 55 years old inclusive at time of consent. * Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive Exclusion Criteria: * History of malignancy (...

Countries:United States
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