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Relative Bioavailability Study of a Modified-Release Formulation of PF-06865571 in Healthy Adult Participants

Last updated on August 6, 2019

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Study Location
Pfizer Clinical Research Unit
Brussels, , B-1070 Belgium
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Participants
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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- Female participants of non-childbearing potential and male participants who are
overtly healthy as determined by medical evaluation including medical history,
physical examination, laboratory tests, and cardiac tests.

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

- Participants enrolling as Japanese must have 4 biological Japanese grandparents who
were born in Japan.

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, neurological, or
allergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at the time of dosing).

- Use of prescription or nonprescription drugs and dietary and herbal supplements within
7 days or 5 half-lives (whichever is longer) prior to the first dose of
investigational product.

- Previous administration with an investigational drug within 30 days (or as determined
by the local requirement) or 5 half-lives preceding the first dose of investigational
product used in this study (whichever is longer).

- Screening supine blood pressure (BP) ?140 mm Hg (systolic) or ?90 mm Hg (diastolic),
following at least 5 minutes of supine rest.

- Baseline 12-lead electrocardiogram (ECG) that demonstrates clinically relevant
abnormalities that may affect participant safety or interpretation of study results
(eg, baseline corrected QT (QTc) interval >450 msec, complete left bundle branch block
[LBBB], signs of an acute or indeterminate-age myocardial infarction, ST-T interval
changes suggestive of myocardial ischemia, second- or third-degree atrioventricular
[AV] block, or serious bradyarrhythmias or tachyarrhythmias).

- Participants with any of the following abnormalities in clinical laboratory tests at
screening: Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level
?1.25× upper limit of normal (ULN); Total bilirubin level ?1.5× ULN; participants with
a history of Gilbert's syndrome may have direct bilirubin measured and would be
eligible for this study provided the direct bilirubin level is ? ULN.

NCT04044053
Pfizer
Not yet recruiting
Relative Bioavailability Study of a Modified-Release Formulation of PF-06865571 in Healthy Adult Participants

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