Study Evaluating Effects of Multiple-Dose Administration of Itraconazole on the Single Dose Pharmacokinetics of Conjugated Estrogens/Bazedoxifene in Non-Obese and Obese Postmenopausal Women

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CE/BZA; Drug: Itraconazole

• Registration Number: NCT02100553
• Lead Sponsor: Pfizer

Brief Summary

This study will assess if itraconazole will affect the blood levels of Duavee when they are given together. This study will also assess if a subject's body size affects the blood levels of Duavee.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-27
• Study Start: 2014-04
• Study First Posted: 2014-04-01
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese	Itraconazole	BMI \>= 30 kg/m\^2
Non-Obese	CE/BZA	BMI \<30 kg/m\^2
Obese	CE/BZA	BMI \>= 30 kg/m\^2
Non-Obese	Itraconazole	BMI \<30 kg/m\^2

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Apparent Volume of Distribution (Vz/F) for all analytes.	up to 96 hours	Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Terminal Phase Elimination Half-Life (t1/2) for all analytes.	up to 96 hours	Terminal Phase Elimination Half-Life is the time measured for the plasma concentration to decrease by one half.
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	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).
Apparent Oral Clearance (CL/F) for all analytes.	up to 96 hours	Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Time to Reach Maximum Observed Plasma Concentration (Tmax) for all analytes.	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

Trial Locations

Locations (2)

SeaView Research, Inc. (Screening Office); 🇺🇸 Miami, Florida, United States

SeaView Research, Inc.; 🇺🇸 Miami, Florida, United States