Status:
TERMINATED
A Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 In Japanese Healthy Adult Volunteers
Lead Sponsor:
Pfizer
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
Investigation of safety, tolerability, and pharmacokinetics of PF-00868554 following multiple oral administrations of PF-00868554 in Japanese healthy adult volunteers.
Detailed Description
Study A8121018 was prematurely discontinued due to FDA instructions stating that Study A8121018 could not be performed under US IND 78,910, which was provided by the meeting on August 13, 2009. And th...
Eligibility Criteria
Inclusion
- Healthy male and female Japanese 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).
Exclusion
- Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
- Exposure within the previous three months to a drug known to have a negative effect on skeletal muscle or reproductive organs.
- Pregnant or nursing females; females of childbearing potential.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00875628
Start Date
April 1 2009
End Date
April 1 2009
Last Update
October 22 2009
Active Locations (1)
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1
Pfizer Investigational Site
Glendale, California, United States, 91206