A First In Human Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Single Rising Doses In Healthy Adult Volunteers

Completed · Phase 1 · Has a placebo group

Conditions studied: Bipolar Depression

In brief

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-04455242-01 in healthy adult volunteers.

Key facts

Study ID

NCT00938301

Run by

Pfizer

People needed

18

Starts

2009-04-01

Expected to finish

2009-07-01

Last updated by the study team

2009-10-16

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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