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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01362673
Recruitment Status : Completed
First Posted : May 30, 2011
Last Update Posted : October 7, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

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: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
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 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01362673


Locations
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United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01362673    
Other Study ID Numbers: A9391012
First Posted: May 30, 2011    Key Record Dates
Last Update Posted: October 7, 2011
Last Verified: October 2011
Keywords provided by Pfizer:
Phase 1
Pharmacokinetics
food effect
Healthy Japanese
rheumatoid arthritis