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Multiple Dose Study Of PF-05251749 In Healthy Volunteers

Last updated on March 14, 2019

Study Location
QPS-MRA, LLC (Miami Research Associates)
South Miami, Florida, 33143 United States
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Adult Subjects, Healthy Elderly Subjects
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-85 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy male and/or female subjects of non-childbearing potential between the ages of
18 and 55 years (Parts A and B) or 65 and 85 years (Part C), 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 and clinical laboratory tests).

- Female subjects of non-childbearing potential must meet at least one of the following

1. Achieved postmenopausal status, defined as follows: cessation of regular menses
for at least 12 consecutive months with no alternative pathological or
physiological cause; and have a serum follicle-stimulating hormone (FSH) level
confirming the post-menopausal 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) will be 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 lbs).

- 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 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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- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

- Treatment with an investigational drug within 30 days (or as determined by the local
requirement) or 5 half-lives preceding the first dose of study medication (whichever
is longer).

- Screening supine blood pressure >= 140 mm Hg (systolic) or >=90 mm Hg (diastolic),
following at least 5 minutes of rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg
(diastolic), repeat per local standard operating procedures (SOP). If orthostatic
changes are present and deemed to be clinically significant by the investigator,
Subject can be excluded.

Multiple Dose Study Of PF-05251749 In Healthy Volunteers


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