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

Pfizer27 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

PF-04171327DRUG

Oral single 5 mg dose as one 5 mg tablet

PF-04171327DRUG

Oral single 10 mg dose as one 10 mg tablet

PF-04171327DRUG

Oral single 30 mg dose as three 10 mg tablets

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Pfizer Investigational Site

Glendale, California, United States

Outcomes

Primary Outcomes

Plasma pharmacokinetic parameters for PF-00251802 : Cmax

Time frame: Day 1 to Day 4 in each period of Cohort A

Plasma pharmacokinetic parameters for PF-00251802 : Tmax

Time frame: Day 1 to Day 4 in each period of Cohort A

Plasma pharmacokinetic parameters for PF00251802 : AUC(0-last)

Time frame: Day 1 to Day 4 in each period of Cohort A

Plasma pharmacokinetic parameters for PF-00251802 : As data permit AUC(0-inf)

Time frame: Day 1 to Day 4 in each period of Cohort A

Plasma pharmacokinetic parameters for PF-00251802 : As data permit t1/2

Time frame: Day 1 to Day 4 in each period of Cohort A

Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax

Time frame: Day 1 to Day 4 in each period of Cohort A

Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax

Time frame: Day 1 to Day 4 in each period of Cohort A

Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUC(0-last)

Time frame: Day 1 to Day 4 in each period of Cohort A

Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit AUC(0-inf)

Time frame: Day 1 to Day 4 in each period of Cohort A

Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2

Time frame: Day 1 to Day 4 in each period of Cohort A

Data from ClinicalTrials.gov

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Oral single dose as matching placebo

PF-04171327DRUG

Oral multiple 20 mg doses as two 10 mg tablets for 12 days

PlaceboDRUG

Oral multiple doses as matching placebo for 12 days

Plasma pharmacokinetic parameters for PF-00251802: Cmax for Day 1 and Day 12