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Bioavailability and Food Effect Study of Two Formulations of PF-06650833

Last updated on April 23, 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
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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- Healthy female subjects of nonchild bearing potential and/or male subjects who, at the
time of screening, are between the ages of 18 and 55 years, inclusive.

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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects with any of the following characteristics/conditions will not be included in
the study:

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).

Any condition possibly affecting drug absorption (eg, gastrectomy).

- A positive urine drug test.

- History of regular alcohol consumption within 6 months before screening.

- Treatment 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
(whichever is longer).

- Screening supine BP greater than equal to 140 mm Hg (systolic) or more than equal to
90 mm Hg (diastolic), following at least 5 minutes of supine rest.

- Pregnant female subjects; breastfeeding female subjects; female subjects of
childbearing potential;

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

- History of tuberculosis or active or latent or inadequately treated infection,
positive QuantiFERON-TB Gold test.

History of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C; positive
testing for HIV, hepatitis B surface antigen (HepBsAg), hepatitis B core antibody
(HepBcAb), or hepatitis C antibody (HCVAb).

-Other acute or chronic medical or psychiatric condition including recent (within the past
year) or active suicidal ideation or behavior or laboratory abnormality

NCT03308110
Pfizer
Completed
Bioavailability and Food Effect Study of Two Formulations of PF-06650833

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Pfizer Clinical Trials Contact Center

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