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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Bipolar Depression

Treatments

Drug: PF-04455242

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00938301

B1071001

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.