Recent Updates
Recently added Catalysts

Experimental

Phase 1

Healthy Volunteers | Small molecule | Other |Biogen Inc.|Last Updated: Nov 4, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment80
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01420458Study in Healthy Volunteers to Establish the BioEquivalence of Two Formulations of BG00012PHASE1 COMPLETED 80 — — Aug 1, 2011Sep 1, 2011Nov 4, 20111 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Area under the plasma concentration curve as a measure of PK.
Participants will be followed during the duration of the study, 4 days. Samples taken at -15mins, 30 mins, 60 mins, 90 mins, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 7 hrs, 8 hrs, 10 hrs, 12 hrs
Secondary Endpoints
The number of AEs in participants as a measure of safety and tolerability.
Participants will be followed during the time of study - an estimated four days
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
Interventions
NameTypeDescription
ExperimentalDRUGBioequivalence of two drug formulations
Unlock Study Design Details
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
Unlock Eligibility Criteria