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BG9928

Phase 1

Hepatic Impairment | Small molecule | Gastrointestinal |Biogen Inc.|Last Updated: Jan 27, 2010

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 Enrollment23
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00858156BG9928 in Subjects With Hepatic ImpairmentPHASE1 COMPLETED 23 — — Apr 1, 2009Aug 1, 2009Jan 27, 20102 United States
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Study Endpoints
Primary Endpoints
The comparative effect of hepatic function on the pharmacokinetics of a single oral dose of BG9928 in subjects with mild and moderate hepatic impairment as compared to subjects with normal hepatic function
1 week post dose
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
Interventions
NameTypeDescription
BG9928DRUGOral 75 mg single dose
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Must be between the ages of 18 and 75, inclusive. * Must have a Body Mass Index (BMI) between 19 kg/m2 and 36 kg/m2, inclusive. The following criteria apply only to subjects enrolled into Groups 1 and 2 (mild or moderate hepatic impairment): * Must have stable hepatic diseas...

Countries:United States
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