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Glucagen

Phase 1

Hypoglycemia | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 20, 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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment28
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00745186Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy VolunteersPHASE1 COMPLETED 28 — — Aug 1, 2007Mar 1, 2008Mar 20, 20171 United Kingdom
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Study Endpoints
Primary Endpoints
Area Under the Curve from Time 0 to the Last Time Point (AUC0-tlast) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Maximum Glucagon Concentration Observed (Cmax) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Maximum Blood Glucose Concentration Observed (BG Cmax) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20,25,30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Secondary Endpoints
Area under the curve from time 0 extrapolated to infinity (AUC0-inf) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Time at which Cmax occurs (Tmax) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20, 25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
Elimination half life (T1/2) for 1 mg Dose Level
Pre-dose: 20, 10 and 5 min; Post-dose: 5, 10, 15, 20,25, 30, 35, 40, 45, 60, 90, 120, 150, 180 and 240 minutes.
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORGlucagen
2EXPERIMENTALMayne Glucagon
Interventions
NameTypeDescription
GlucagenDRUG0.2 mg or 1 mg Glucagen single injection
Mayne GlucagonDRUG0.2 mg or 1 mg Mayne Glucagon
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Eligibility Criteria
Age Range18 Years — 50 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy Male or female aged 18-50 years inclusive * Body weight between 50 - 100 kg and body mass index (BMI) between 18 and 30 kg/m2 or, if outside the range, considered not clinically significant by the investigator * Non-smokers or ex-smokers who have not smoked with in the...

Countries:United Kingdom
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