PK And Safety Study Of PF-04171327 In Healthy Japanese And Western Subjects In Fasting And Fed Conditions

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

This Phase 1 study is the first clinical trial in Japanese subjects. This study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of PF-04171327 oral tablet in healthy adult Japanese and Western subjects in fasting and fed conditions.

Key facts

Study ID

NCT01362673

Run by

Pfizer

People needed

27

Starts

2011-05-01

Expected to finish

2011-08-01

Last updated by the study team

2011-10-07

Who can join

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

You may qualify if…

• Healthy male and/or female subjects of non childbearing potential between the ages of 18 and 55 years.
• Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >45 kg (99 lbs).
• Japanese subjects who have four Japanese grandparents born in Japan.

You may not qualify if…

• Confirmed fasting glucose more than 100 mg/dL at Screening and Day 0 in both Cohort A and B.
• Corticosteroid use of more than 5 mg prednisone equivalent per day for more than 6 weeks.
• Evidence or history of clinically significant hematological (including anemia), 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).

Where it is running

• Pfizer Investigational Site — Glendale, California, United States

Full record on ClinicalTrials.gov

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