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

A Phase 1, Randomized, Subject- And Investigator Blind, Sponsor Open, Placebo Controlled, Single- And Multiple-Dose Escalation Study Of PF-04171327 In Healthy Adult Japanese And Western Subjects In Fasting And Fed Conditions

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: PF-04171327; Drug: PF-04171327; Drug: PF-04171327; Drug: PF-04171327; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Glendale, California, United States, 91206
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose	Drug: Placebo; Oral single dose as matching placebo; Drug: PF-04171327; Oral single 5 mg dose as one 5 mg tablet; Drug: PF-04171327; Oral single 10 mg dose as one 10 mg tablet; Drug: PF-04171327; Oral single 30 mg dose as three 10 mg tablets; Drug: PF-04171327; Oral multiple 20 mg doses as two 10 mg tablets for 12 days; Drug: Placebo; Oral multiple doses as matching placebo for 12 days
Experimental: Multiple dose	Drug: Placebo; Oral single dose as matching placebo; Drug: PF-04171327; Oral single 5 mg dose as one 5 mg tablet; Drug: PF-04171327; Oral single 10 mg dose as one 10 mg tablet; Drug: PF-04171327; Oral single 30 mg dose as three 10 mg tablets; Drug: PF-04171327; Oral multiple 20 mg doses as two 10 mg tablets for 12 days; Drug: Placebo; Oral multiple doses as matching placebo for 12 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma pharmacokinetic parameters for PF-00251802 : Cmax	Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802 : Tmax	Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF00251802 : AUC(0-last)	Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802 : As data permit AUC(0-inf)	Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802 : As data permit t1/2	Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax	Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax	Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUC(0-last)	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)	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	Day 1 to Day 4 in each period of Cohort A
Plasma pharmacokinetic parameters for PF-00251802: Cmax for Day 1 and Day 12	Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: Tmax for Day 1 and Day 12	Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: AUCtau for Day 1 and Day 12	Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: As data permit t1/2 for Day12	Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12	Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for PF-00251802: Ctrough	Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax for Day 1 and Day 12	Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax for Day 1 and Day 12	Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUCtau for Day 1 and Day 12	Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2 for Day12	Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12	Day 1 to Day 15 in Cohort B
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Ctrough	Day 1 to Day 15 in Cohort B

Secondary Outcome Measures

Outcome Measure	Time Frame
Biomarkers for bone effects: Serum procollagen type 1 N-terminal propeptide (P1NP), serum C terminal telopeptide of type I collagen (CTX), serum osteocalcin and urine N terminal telopeptide of type I collagen (uNTX).	Day 0 to Day 15 in Cohort B
Biomarkers for carbohydrate and metabolic: Plasma cortisol, serum glucose, plasma insulin and serum adiponectin.	Day 0 to Day 15 in Cohort B

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: May 17, 2011
• First Submitted That Met QC Criteria: May 26, 2011
• First Posted (Estimate): May 30, 2011

Study Record Updates

• Last Update Posted (Estimate): October 7, 2011
• Last Update Submitted That Met QC Criteria: October 5, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; Pharmacokinetics; Phase 1; food effect; Healthy Japanese
• Other Study ID Numbers: A9391012