NCT01362673

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2011

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 30, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

October 7, 2011

Status Verified

October 1, 2011

Enrollment Period

3 months

First QC Date

May 17, 2011

Last Update Submit

October 5, 2011

Conditions

Healthy

Keywords

Phase 1Pharmacokineticsfood effectHealthy Japaneserheumatoid arthritis

Outcome Measures

Primary Outcomes (22)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Single dose

EXPERIMENTAL
Drug: PF-04171327Drug: Placebo

Multiple dose

EXPERIMENTAL
Drug: PF-04171327Drug: Placebo

Interventions

PF-04171327DRUG

Oral single 5 mg dose as one 5 mg tablet

Single dose
PlaceboDRUG

Oral single dose as matching placebo

Single dose

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

Glendale, California, 91206, United States

Location

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

fosdagrocorat

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2011

First Posted

May 30, 2011

Study Start

May 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

October 7, 2011

Record last verified: 2011-10

Locations

US(1)