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A Study In Japanese Healthy Male Volunteers To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-02341066

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Hachioji-shi, Tokyo, Japan
Contact
1-800-718-1021
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
20-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male subjects, inclusive (Healthy is defined as no clinically relevant
abnormalities identified by a detailed medical history, full physical examination,
including blood pressure and pulse rate measurement, 12-lead ECG and clinical
laboratory tests).

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

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

- Subjects who are smoking,

- Subjects with evidence of disease,

- Subjects with conditions affecting absorption,

- Subjects with treatment with other investigational drug within 30 days,

- Subjects with history of regular alcohol consumption,

- Subjects with use of prescription, nonprescription drugs and dietary supplement within
28 days,

- Subjects with blood donation of approximately 400 mL within 3 months or 200 mL within
1 month prior to dosing

NCT01250730
Pfizer
Completed
A Study In Japanese Healthy Male Volunteers To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-02341066

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A Study In Japanese Healthy Male Volunteers To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-02341066
A Phase 1, Open Label, Dose Escalation, Single Oral Dose Study In Japanese Healthy Male Volunteers To Investigate The Safety, Tolerability And Pharmacokinetics Of PF-02341066
The purpose of this study is to investigate the pharmacokinetics of single doses of PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male volunteers.
The purpose of this study is to investigate the pharmacokinetics of single doses of PF-02341066 (150, 250, and 400 mg) in the fasted condition in Japanese healthy male volunteers.
Interventional
Phase 1
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Healthy
  • Drug: PF-02341066
    Cohort 1: a 150 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 1 x 100 mg IRT.
    Other Name: Not Specified
  • Drug: PF-02341066
    Cohort 2: a 250 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 2 x 100 mg IRTs.
    Other Name: Not Specified
  • Drug: PF-02341066
    Cohort 3: a 400 mg single dose of PF-02341066 administered as 4 x 100 mg IRTs.
    Other Name: Not Specified
Experimental: 1.0
This study will consist of three cohorts: PF-02341066 150 mg treatment group (n = 6), PF-02341066 250 mg treatment group (n = 6) and PF-02341066 400 mg treatment group (n = 6).
Interventions:
  • Drug: PF-02341066
  • Drug: PF-02341066
  • Drug: PF-02341066
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
January 2011
January 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male subjects, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg

Exclusion Criteria:

  • Subjects who are smoking,
  • Subjects with evidence of disease,
  • Subjects with conditions affecting absorption,
  • Subjects with treatment with other investigational drug within 30 days,
  • Subjects with history of regular alcohol consumption,
  • Subjects with use of prescription, nonprescription drugs and dietary supplement within 28 days,
  • Subjects with blood donation of approximately 400 mL within 3 months or 200 mL within 1 month prior to dosing
Sexes Eligible for Study: Male
20 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01250730
A8081022
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

FOR MORE INFORMATION

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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1-800-718-1021

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