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

NCT01362673

Last updated date
Study Location
Pfizer Investigational Site
Glendale, California, 91206, United States
Contact
1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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).

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Advanced Information
Descriptive Information
Brief Title  ICMJE PK And Safety Study Of PF-04171327 In Healthy Japanese And Western Subjects In Fasting And Fed Conditions
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: Single dose
    Interventions:
    • Drug: PF-04171327
    • Drug: PF-04171327
    • Drug: PF-04171327
    • Drug: Placebo
  • Experimental: Multiple dose
    Interventions:
    • Drug: PF-04171327
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 13, 2011)
27
Original Estimated Enrollment  ICMJE
 (submitted: May 26, 2011)
26
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01362673
Other Study ID Numbers  ICMJE A9391012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP