A Study To Understand Safety And Plasma Concentrations Of PF-06669571 During And Following The Oral Administration Of Single And Multiple Doses Of PF-06669571 In Healthy Volunteers Under Fasted And Fed Conditions
Status: | Completed |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 9/8/2018 |
Start Date: | July 2014 |
End Date: | March 2015 |
A Phase 1, Double Blind, Sponsor Open, Placebo Controlled Combined Single And Multiple Ascending Dose Study To Investigate The Safety, Tolerability And Food Effect On Pharmacokinetics Of PF-06669571 Following Oral Doses In Healthy Subjects
This study is designed to evaluate the safety and plasma concentrations of PF-06669571 in
healthy volunteers following single and multiple ascending doses of PF-06669571. Effect of
food on PF-06669571 plasma concentrations will be be evaluated after a single dose of
PF-06669571. During multiple dose phase, PF-06669571 will be administered daily for 14 days
healthy volunteers following single and multiple ascending doses of PF-06669571. Effect of
food on PF-06669571 plasma concentrations will be be evaluated after a single dose of
PF-06669571. During multiple dose phase, PF-06669571 will be administered daily for 14 days
Inclusion Criteria:
- Healthy male and/or female subjects of non-childbearing potential 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 and clinical laboratory tests).
Female subjects of non-childbearing potential must meet at least one of the following
criteria:
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:
- 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.
- For subjects who answer "Yes" to the Columbia Suicide Severity Rating Scale (C-SSRS)
questions 4 or 5, a risk assessment should be done by a qualified mental health
professional (MHP: a psychiatrist or licensed PhD level clinical psychologist) to
assess whether it is safe for the subject to participate in the study. In addition,
subjects deemed by the investigator to be at significant risk of suicidal or violent
behavior should be excluded.
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