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Evaluation Of The Relative Bioavailability Of PF-04457845 Tablet To Solution Formulation And Food Effect In Healthy Subjects

Last updated on February 21, 2019

Study Location
Pfizer Investigational Site
Singapore, , 188770 Singapore
Eligibility criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy Volunteers
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Healthy male subjects or healthy female subjects of non-child bearing potential.
(Healthy is defined as no clinically relevant abnormalities identified by a detailed
medical history, complete physical examination, including blood pressure and pulse
rate measurement, 12-lead ECG and clinical laboratory tests);

- 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 (or a legally acceptable representative) has been informed of all
pertinent aspects of the trial;

- Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other trial procedures;

- Willing and able to consume a non-vegetarian high-fat meal.

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);

- History of febrile illness within 5 days prior to the first dose;

- Any condition possibly affecting drug absorption (eg, gastrectomy);

- A positive urine drug screen;

- History of regular alcohol consumption exceeding 7 drinks/week for females or 14
drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer
or 1.5 ounces (45 mL) of hard liquor) within 6 months of screening;

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

- 12-lead ECG demonstrating QTc >450 msec at screening. If QTc exceeds 450 msec, the ECG
should be repeated two more times and the average of the three QTc values should be
used to determine the subject's eligibility;

- Pregnant or nursing females and females of child-bearing potential;

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

- Herbal supplements and hormone replacement therapy must be discontinued 28 days prior
to the first dose of trial medication. Other exceptions may be granted by a qualified
member of Pfizer study management;

- Unwillingness to refrain from consumption of grapefruit/pomelo or
grapefruit/pomelocontaining products from 7 days prior to the first dose of study
medication until the completion of the follow-up visit.

- Blood donation of approximately 1 unit (~500 mL) within 56 days prior to dosing;

- Unwillingness or inability to comply with the Lifestyle guidelines;

- Subject is the Investigator or sub-Investigator, research assistant, pharmacist, study
coordinator, other staff, or a relative of study personnel directly involved with the
conduct of the study;

- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with trial participation or
investigational product administration or may interfere with the interpretation of
trial results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this trial.

Evaluation Of The Relative Bioavailability Of PF-04457845 Tablet To Solution Formulation And Food Effect In Healthy Subjects


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