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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 (CE/BZA)

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ClinicalTrials.gov Identifier: NCT02100553
Recruitment Status : Completed
First Posted : April 1, 2014
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: CE/BZA Drug: Itraconazole Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official 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
Study Start Date : April 2014
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Non-Obese
BMI <30 kg/m^2
Drug: CE/BZA
CE 0.45mg/BZA 20mg tablets, single dose
Other Name: Duavee

Drug: Itraconazole
Two 100 mg capsules, once daily for 7 days
Other Name: Sporanox

Drug: CE/BZA
CE 0.45mg/BZA 20mg tablets, single dose on Day 5
Other Name: Duavee

Obese
BMI >= 30 kg/m^2
Drug: CE/BZA
CE 0.45mg/BZA 20mg tablets, single dose
Other Name: Duavee

Drug: Itraconazole
Two 100 mg capsules, once daily for 7 days
Other Name: Sporanox

Drug: CE/BZA
CE 0.45mg/BZA 20mg tablets, single dose on Day 5
Other Name: Duavee




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02100553


Locations
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United States, Florida
SeaView Research, Inc. (Screening Office)
Miami, Florida, United States, 33125
SeaView Research, Inc.
Miami, Florida, United States, 33126
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02100553    
Other Study ID Numbers: B2311065
First Posted: April 1, 2014    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015
Keywords provided by Pfizer:
Postmenopausal Women
Obese
Non-obese
Drug Interaction with Itraconazole
Pharmacokinetic
Additional relevant MeSH terms:
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Itraconazole
Hydroxyitraconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors