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CE/BZA

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Mar 25, 2015

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
CONTROLLED
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02100553Study Evaluating Effects of Multiple-Dose Administration of Itraconazole on the Single Dose Pharmacokinetics of Conjugated Estrogens/Bazedoxifene in Non-Obese and Obese Postmenopausal WomenPHASE1 COMPLETED 24 — — Apr 1, 2014Jun 1, 2014Mar 25, 20152 United States
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Study Endpoints
Primary Endpoints
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for BZA, total estrone adjusted for baseline and total equilin.
up to 96 hours

AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf).

Maximum Observed Plasma Concentration (Cmax) for BZA, total estrone adjusted for baseline and total equilin.
up to 96 hours
Secondary Endpoints
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for unconjugated estrone, unconjugated estrone adjusted for baseline, total estrone, and unconjugated equilin.
up to 96 hours
Maximum Observed Plasma Concentration (Cmax) for unconjugated estrone, unconjugated estrone adjusted for baseline, total estrone, and unconjugated equilin.
up to 96 hours
Apparent Oral Clearance (CL/F) for all analytes.
up to 96 hours
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Non-ObeseOTHERBMI \<30 kg/m\^2
ObeseOTHERBMI \>= 30 kg/m\^2
Interventions
NameTypeDescription
CE/BZADRUGCE 0.45mg/BZA 20mg tablets, single dose
ItraconazoleDRUGTwo 100 mg capsules, once daily for 7 days
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Eligibility Criteria
Age Range40 Years — 64 Years
SexFEMALE
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Generally healthy postmenopausal women, aged 40-64. Intact Uterus Exclusion Criteria: * The use of oral, vaginal, or transdermal estrogen, androgen or progestin-containing medications within 30 days before study drug administration.

Countries:United States
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