Overview

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

Status:
Completed
Trial end date:
2009-07-01
Target enrollment:
0
Participant gender:
All
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-04455242-01 in healthy adult volunteers.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Pfizer
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.