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Completed

NCT Number: NCT02100553

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

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.

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Key information

Conditions

Healthy Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

SeaView Research, Inc., Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CE/BZA

Drug

CE 0.45mg/BZA 20mg tablets, single dose

Other names: Duavee

Itraconazole

Drug

Two 100 mg capsules, once daily for 7 days

Other names: Sporanox

Primary outcomes

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] for BZA, total estrone adjusted for baseline and total equilin.

    Time frame: 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).

  2. Maximum Observed Plasma Concentration (Cmax) for BZA, total estrone adjusted for baseline and total equilin.

    Time frame: up to 96 hours

Secondary outcomes

  1. 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.

    Time frame: 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).

  2. Maximum Observed Plasma Concentration (Cmax) for unconjugated estrone, unconjugated estrone adjusted for baseline, total estrone, and unconjugated equilin.

    Time frame: up to 96 hours

  3. Apparent Oral Clearance (CL/F) for all analytes.

    Time frame: 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.

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax) for all analytes.

    Time frame: up to 96 hours

  5. Apparent Volume of Distribution (Vz/F) for all analytes.

    Time frame: 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.

  6. Terminal Phase Elimination Half-Life (t1/2) for all analytes.

    Time frame: up to 96 hours

    Terminal Phase Elimination Half-Life is the time measured for the plasma concentration to decrease by one half.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A Phase 1, Open Label, Two Period, Fixed Sequence, Parallel Group Study To Estimate The Effects Of Multiple Dose Administration Of Itraconazole On The Single Dose Pharmacokinetics Of Conjugated Estrogens/Bazedoxifene In Non Obese (Bmi <30 Kg/m2) And Obese (Bmi ≥30 Kg/m2) Postmenopausal Women

Acronym: CE/BZA

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Apr 1, 2014
Registry last updated
Mar 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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