Status:
COMPLETED
A First In Human Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Single Rising Doses In Healthy Adult Volunteers
Lead Sponsor:
Pfizer
Conditions:
Bipolar Depression
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this first in human (FIH) study is to investigate the safety, tolerability, pharmacokinetics ( how the body handles the drug) and pharmacodynamics (how the drug affects the body) of PF-...
Eligibility Criteria
Inclusion
- Healthy male and/or female of non-childbearing potential between the ages of 18 and 55 years.
- Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (\>110 lbs).
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Exclusion
- Evidence or history of clinically significant medical condition or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening).
- Use of tobacco- or nicotine-containing products within 3 months of screening or a positive urine or blood cotinine at screening.
- A positive urine drug screen. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00938301
Start Date
April 1 2009
End Date
July 1 2009
Last Update
October 16 2009
Active Locations (1)
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1
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511-5473