Recent Updates
Recently added Catalysts

BMN 673

Phase 1

Human Volunteers | Small molecule | Other |Pfizer, Inc.|Last Updated: Jul 28, 2017

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
RandomizedCONTROLLEDBiomarker
Total Trials1
Total Enrollment18
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01776437Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male VolunteersPHASE1 COMPLETED 18 — — Feb 1, 2013Jul 1, 2013Jul 28, 20171 United States
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
The primary outcome of this study is to evaluate the effect of food on the relative bioavailability of BMN 673. The Pharmacokinetic analyses of plasma BMN 673 concentration-time will be measured using non-compartmental methods.
4 months
Secondary Endpoints
Assess the safety and tolerability of BMN 673 during fasting and fed conditions with the following safety assessments: adverse events, physical examination, vital signs, concomitant medications, clinical laboratory tests and ECG.
4 months
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER
Treatment Arms
ArmTypeDescription
Treatment AEXPERIMENTALPeriod 1: fasted control → Period 2: fed control
Treatment BEXPERIMENTALPeriod 1: fed control → Period 2: fasted control
Interventions
NameTypeDescription
BMN 673DRUG500mcg dose of BMN 673, 2 discrete single doses separated by 21 days
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male, between the ages of 18 and 55. * Non-smoking for at least 1 year before Screening. * Willing and able to provide informed consent. * Have a BMI between 18 to 30kg/m2. * Willing and able to comply all study procedures. * Have adequate organ function * Sexually active pati...

Countries:United States
Unlock Eligibility Criteria