Completed
A Phase 1 Open-Label Fixed-Sequence Two-Period Crossover Study Of The Effect Of Multiple Doses Of Tamoxifen On PD-0332991 Pharmacokinetics In Healthy Male Volunteers
What is being tested
PD-0332991 alone
+ Tamoxifen 60 mg
+ Tamoxifen 20 mg
Drug
Who is being recruted
From 18 to 55 Years
+6 Eligibility Criteria
How is the trial designed
Basic Science Study
Phase 1
Interventional
Study Start: April 2013
Summary
Principal SponsorPfizer
Last updated: October 8, 2015
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2013
Actual date on which the first participant was enrolled.A single 125 mg oral dose of the investigational compound PD-0332991 will be administered alone and after steady-state dosing of tamoxifen to determine if coadministration of tamoxifen alters the plasma pharmacokinetics of PD-0332991 in healthy male volunteers.
Principal SponsorPfizer
Last updated: October 8, 2015
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Basic Science Study
Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Male
Biological sex of participants that are eligible to enroll.From 18 to 55 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
3 inclusion criteria required to participate
Body mass index (BMI) between 17.5 and 30.5 kg/m2
Healthy male between the ages of 18 and 55 years of age inclusive
Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures
3 exclusion criteria prevent from participating
Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
a positive urine drug screen
a supine systolic blood pressure > 140 mm Hg, or diastolic blood pressure > 90 mm H
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalThis arm is comprised of two treatment periods in fixed sequence.
Period 1 is 7 days long, while Period 2 is 28 days long.
In Period 1 the subjects receive a single 125 mg oral dose of PD-0332991 on Day 1.
In Period 2 the subjects receive 4 daily 60 mg oral doses of tamoxifen (Days 1-4), followed by 23 daily 20 mg oral doses of tamoxifen (Days 5-27).
On Day 22 of Period 2 the subjects receive a second 125 mg oral dose of PD-0332991.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
CompletedOne Study Center