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Completed

NCT Number: NCT01362673

PK And Safety Study Of PF-04171327 In Healthy 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.

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Key information

Conditions

Healthy Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Glendale, California, 91206, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PF-04171327

Drug

Oral single 5 mg dose as one 5 mg tablet

Placebo

Drug

Oral single dose as matching placebo

Primary outcomes

  1. Plasma pharmacokinetic parameters for PF-00251802 : Cmax

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

  2. Plasma pharmacokinetic parameters for PF-00251802 : Tmax

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

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

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

  4. 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

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

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

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

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

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

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

  8. 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

  9. 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

  10. 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

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

    Time frame: Day 1 to Day 15 in Cohort B

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

    Time frame: Day 1 to Day 15 in Cohort B

  13. Plasma pharmacokinetic parameters for PF-00251802: AUCtau for Day 1 and Day 12

    Time frame: Day 1 to Day 15 in Cohort B

  14. Plasma pharmacokinetic parameters for PF-00251802: As data permit t1/2 for Day12

    Time frame: Day 1 to Day 15 in Cohort B

  15. Plasma pharmacokinetic parameters for PF-00251802: As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12

    Time frame: Day 1 to Day 15 in Cohort B

  16. Plasma pharmacokinetic parameters for PF-00251802: Ctrough

    Time frame: Day 1 to Day 15 in Cohort B

  17. Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Cmax for Day 1 and Day 12

    Time frame: Day 1 to Day 15 in Cohort B

  18. Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Tmax for Day 1 and Day 12

    Time frame: Day 1 to Day 15 in Cohort B

  19. Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): AUCtau for Day 1 and Day 12

    Time frame: Day 1 to Day 15 in Cohort B

  20. Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit t1/2 for Day12

    Time frame: Day 1 to Day 15 in Cohort B

  21. Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): As data permit Rac (accumulation ratio = Day 12 AUCtau/Day 1 AUCtau) for Day12

    Time frame: Day 1 to Day 15 in Cohort B

  22. Plasma pharmacokinetic parameters for N-oxide metabolite (PF-04015475): Ctrough

    Time frame: Day 1 to Day 15 in Cohort B

Secondary outcomes

  1. 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).

    Time frame: Day 0 to Day 15 in Cohort B

  2. Biomarkers for carbohydrate and metabolic: Plasma cortisol, serum glucose, plasma insulin and serum adiponectin.

    Time frame: Day 0 to Day 15 in Cohort B

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
May 30, 2011
Registry last updated
Oct 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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