Pharmacokinetics, Safety and Tolerability Study of PF-03463275 in Healthy Male Japanese and Western Subjects

NCT01159626

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

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
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 subjects 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 >50 kg (110 lbs).

- Japanese subjects must have four Japanese grandparents who were born in Japan.

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


- Subjects that are genotyped to be PM (poor metabolizer), UM (ultrarapid metabolizer),
IM/EM and EM/UM for CYP2D6 status.


- 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 time of dosing).

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Advanced Information
Descriptive Information
Brief Title  ICMJE Pharmacokinetics, Safety and Tolerability Study of PF-03463275 in Healthy Male Japanese and Western Subjects
Official Title  ICMJE A Phase 1, Randomized, Subject- and Investigator-blind, Sponsor-open, Placebo-controlled, Single- and Multiple-dose Escalation Study to Investigate the Pharmacokinetics, Safety and Tolerability of PF-03463275 in Healthy Male Japanese and Western Subjects
Brief Summary This Phase 1 study is the first clinical trial in Japanese subjects. The study is designed to evaluate the single- and multiple-dose pharmacokinetics, safety and tolerability of PF-03463275 oral controlled release formulation in Japanese and Western male subjects.
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-03463275
    Oral single 20 mg dose as two 10mg controlled release tablets
  • Drug: PF-03463275
    Oral single 40 mg dose as four 10mg controlled release tablets
  • Drug: PF-03463275
    Oral single 60 mg dose as six 10mg controlled release tablets
  • Drug: Placebo
    Oral single dose as matching placebo
  • Drug: PF-03463275
    Oral multiple 40 mg doses as four 10mg controlled release tablets for 7 days
  • Drug: Placebo
    Oral multiple doses as matching placebo for 7 days
Study Arms  ICMJE
  • Experimental: Single dose
    Interventions:
    • Drug: PF-03463275
    • Drug: PF-03463275
    • Drug: PF-03463275
    • Drug: Placebo
  • Experimental: Multiple dose
    Interventions:
    • Drug: PF-03463275
    • 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: April 19, 2011)
40
Original Estimated Enrollment  ICMJE
 (submitted: July 8, 2010)
39
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male subjects 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 >50 kg (110 lbs).
  • Japanese subjects must have four Japanese grandparents who were born in Japan.

Exclusion Criteria:

  • Subjects that are genotyped to be PM (poor metabolizer), UM (ultrarapid metabolizer), IM/EM and EM/UM for CYP2D6 status.
  • 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 time of dosing).
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
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 NCT01159626
Other Study ID Numbers  ICMJE A9131010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date April 2011

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