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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Glendale, California, 91206 United States
Contact
1-800-718-1021
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).

NCT01362673
Pfizer
Completed
PK And Safety Study Of PF-04171327 In Healthy Japanese And Western Subjects In Fasting And Fed Conditions

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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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Healthy
  • 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
  • Experimental: Single dose
    Interventions:
    • Drug: PF-04171327
    • Drug: PF-04171327
    • Drug: PF-04171327
    • Drug: Placebo
  • Experimental: Multiple dose
    Interventions:
    • Drug: PF-04171327
    • Drug: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
27
August 2011
August 2011   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01362673
A9391012
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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