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

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT01362673

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

8.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: PF-04171327 Drug: PF-04171327 Drug: PF-04171327 Drug: Placebo Drug: PF-04171327 Drug: Placebo	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

27 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2011

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Single dose	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: Placebo Oral single dose as matching placebo
Experimental: Multiple dose	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

Arm

Intervention/Treatment

Experimental: Single dose

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: Placebo

Oral single dose as matching placebo

Experimental: Multiple dose

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).