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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PF-04171327; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01362673

A9391012

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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27 participants in 2 patient groups

Single dose

Experimental group

Treatment:

Drug: Placebo

Drug: PF-04171327

Drug: Placebo

Drug: PF-04171327

Drug: PF-04171327

Drug: PF-04171327

Multiple dose

Experimental group

Treatment:

Drug: Placebo

Drug: PF-04171327

Drug: Placebo

Drug: PF-04171327

Drug: PF-04171327

Drug: PF-04171327