Study To Assess The Pharmacokinetics Of 2 Different Formulations Of PF-04991532

Completed · Phase 1

Conditions studied: Healthy

In brief

This study is designed to compare the pharmacokinetics of two different lots of tablets.

Key facts

Study ID

NCT01388829

Run by

Pfizer

People needed

10

Starts

2011-07-01

Expected to finish

2011-08-01

Last updated by the study team

2011-08-10

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Healthy male and/or female (non childbearing potential) subjects 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. Women must be of non childbearing potential as defined in Lifestyle Guidelines.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
• An informed consent document signed and dated by the subject or a legally acceptable representative.

You may not qualify if…

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.
• Screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement [confirmed by a single repeat, if necessary] following at least 5 minutes of rest.
• Any condition possibly affecting drug absorption (eg, gastrectomy).

Where it is running

• Pfizer Investigational Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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