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HealthyPhase 1CE/BZANCT02100553

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

A Phase 1 study testing CE/BZA and Itraconazole in people with Healthy, run by Pfizer at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 64 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
CE/BZA and Itraconazole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesUnited States
Study dates
Apr 2014to Jun 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 64 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Generally healthy postmenopausal women, aged 40-64. Intact Uterus

Who cannot join

  • The use of oral, vaginal, or transdermal estrogen, androgen or progestin-containing medications within 30 days before study drug administration.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • SeaView Research, Inc. (Screening Office)

    Miami, Florida, 33125

  • SeaView Research, Inc.

    Miami, Florida, 33126

Other trials in United States

About this study

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

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.

Conditions
Healthy
Being tested
CE/BZA, Itraconazole
Keywords
Postmenopausal Women, Obese, Non-obese, Drug Interaction with Itraconazole, Pharmacokinetic
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CE/BZADrug

    Also called Duavee

    CE 0.45mg/BZA 20mg tablets, single dose

  • ItraconazoleDrug

    Also called Sporanox

    Two 100 mg capsules, once daily for 7 days

  • CE/BZADrug

    Also called Duavee

    CE 0.45mg/BZA 20mg tablets, single dose on Day 5

  • CE/BZADrug

    Also called Duavee

    CE 0.45mg/BZA 20mg tablets, single dose

  • ItraconazoleDrug

    Also called Sporanox

    Two 100 mg capsules, once daily for 7 days

  • CE/BZADrug

    Also called Duavee

    CE 0.45mg/BZA 20mg tablets, single dose on Day 5

Study groups in NCT02100553
Study groupRoleWhat they receive
Non-ObeseOtherBMI <30 kg/m^2
Receives: Drug: CE/BZA; Drug: Itraconazole
ObeseOtherBMI >= 30 kg/m^2
Receives: Drug: CE/BZA; Drug: Itraconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    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).

    Measured: up to 96 hours

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

    Measured: up to 96 hours

Secondary outcomes (6)

  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.

    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).

    Measured: up to 96 hours

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

    Measured: up to 96 hours

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

    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.

    Measured: up to 96 hours

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

    Measured: up to 96 hours

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

    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.

    Measured: up to 96 hours

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

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

    Measured: up to 96 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionJun 2014
  4. Study completionJun 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02100553
Sponsor's protocol ID
B2311065
Acronym
CE/BZA
Status last verified
Mar 2015
First submitted
27 Mar 2014
Last updated
25 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CE/BZA and Itraconazole in people with Healthy, run by Pfizer at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02100553.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.

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