NCT02100553

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Apr 2014

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

2 months

First QC Date

March 27, 2014

Last Update Submit

March 23, 2015

Conditions

Healthy

Keywords

Postmenopausal WomenObeseNon-obeseDrug Interaction with ItraconazolePharmacokinetic

Outcome Measures

Primary Outcomes (2)

  • 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).

    up to 96 hours

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

    up to 96 hours

Secondary Outcomes (6)

  • 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

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

    up to 96 hours

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

    up to 96 hours

  • +1 more secondary outcomes

Study Arms (2)

Non-Obese

OTHER

BMI \<30 kg/m\^2

Drug: CE/BZADrug: Itraconazole

Obese

OTHER

BMI \>= 30 kg/m\^2

Drug: CE/BZADrug: Itraconazole

Interventions

CE/BZADRUG

CE 0.45mg/BZA 20mg tablets, single dose

Also known as: Duavee
Non-Obese
ItraconazoleDRUG

Two 100 mg capsules, once daily for 7 days

Also known as: Sporanox
Non-Obese

Eligibility Criteria

Age40 Years - 64 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

SeaView Research, Inc. (Screening Office)

Miami, Florida, 33125, United States

Location

SeaView Research, Inc.

Miami, Florida, 33126, United States

Location

Related Links

MeSH Terms

Conditions

Obesity

Interventions

Itraconazole

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPiperazines

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2014

First Posted

April 1, 2014

Study Start

April 1, 2014

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

US(2)