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A Comparison Of The Pharmacokinetics Of PF-04191834 Following Single Dose Administration Of A Dispersion Formulation And A Suspension Formulation In Healthy Volunteers

Last updated on February 23, 2019

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Study Location
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 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 or clinical laboratory tests.

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg(110 lbs).

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 the time of dosing).

- Clinical evidence of existing hepatic disease or a medical history of such a condition
in the last year. Subjects with AST or ALT >ULN. Subjects with total bilirubin >ULN
(except those with a documented history of Gilbert's Syndrome). Subjects with
AST/ALT/total bilirubin >ULN and

- Treatment with an investigational drug within 30 days or 5 half-lives (whichever is
longer) preceding the first dose of study medication;

- Use of tobacco- or nicotine-containing products in excess of the equivalent of 5
cigarettes per day;

- Females of childbearing potential.

- Subjects with positive responses (score 1) for suicidality on the Sheehan Suicidality
Tracking Scale (S-STS) (specifically items 1a, 1b, 3, 4, 5, 6, 7, or 9).

NCT01265732
Pfizer
Withdrawn
A Comparison Of The Pharmacokinetics Of PF-04191834 Following Single Dose Administration Of A Dispersion Formulation And A Suspension Formulation In Healthy Volunteers

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