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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01362673

Enrollment

Registered

2011-05-30

Start date

2011-05-31

Completion date

2011-08-31

Last updated

2011-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Phase 1, Pharmacokinetics, food effect, Healthy Japanese, rheumatoid arthritis

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.

Interventions

DRUGPF-04171327

Oral single 5 mg dose as one 5 mg tablet

DRUGPlacebo

Oral single dose as matching placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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).

Design outcomes

Primary

Measure	Time frame
Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Ctrough	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 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

Secondary

Measure	Time frame
Biomarkers for carbohydrate and metabolic: Plasma cortisol, serum glucose, plasma insulin and serum adiponectin.	Day 0 to Day 15 in Cohort B
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026