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Glasdegib Absolute Bioavailability Study

Last updated on March 14, 2019

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Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-254-6398
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteer Study
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Inclusion Criteria:

- Healthy male and/or female subjects of non-child bearing potential who, at the time of
screening, are between the ages of 18 and 55 years, inclusive. Healthy is defined as
no clinically relevant abnormalities identified by a detailed medical history, full
physical examination, including blood pressure and pulse rate measurement, 12-lead ECG
or clinical laboratory tests. Female subjects of nonchildbearing potential must meet
at least 1 of the following criteria:

1. Achieved postmenopausal status, defined as follows: cessation of regular menses
for at least 24 consecutive months with no alternative pathological or
physiological cause; with a serum follicle-stimulating hormone (FSH) level
confirming the postmenopausal state;

2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;

3. Have medically confirmed ovarian failure. All other female subjects (including
females with tubal ligations and females that do NOT have a documented
hysterectomy, bilateral oophorectomy and/or ovarian failure) are considered to be
of childbearing potential.

- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lb).

- Evidence of a personally signed and dated informed consent document indicating that
the subject has been informed of all pertinent aspects of the study. -. Subjects who
are willing and able to comply with all scheduled visits, treatment plan, laboratory
tests, and other study procedures.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- -A positive urine drug test.

- Screening supine 12-lead ECG demonstrating a corrected QT (QTc) interval >450 msec or
a QRS interval >120 msec. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG
should be repeated 2 more times and the average of the 3 QTc or QRS values should be
used to determine the subject's eligibility.

- Subjects with family history of myocardial infarction, congenital long QT syndrome,
torsades de pointes or clinically significant ventricular arrhythmias. Subjects should
be within normal range of potassium, magnesium and corrected calcium calculation at
screening.

- Pregnant female subjects; breastfeeding female subjects; female subjects of
childbearing potential; male subjects with partners currently pregnant; male subjects
who are unwilling or unable to use two highly effective methods of contraception as
outlined in this protocol for the duration of the study and for at least 90 days after
the last dose of investigational product and, refrain from sperm donation for the
duration of the Study and for at least 90 days after the last dose of investigational
product.

NCT03270878
Pfizer
Completed
Glasdegib Absolute Bioavailability Study

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