NCT00938301

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

A Phase 1, Placebo-Controlled, Crossover Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04455242 After First-Time Administration Of Single Ascending Doses To Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	PF-04455242	Powder-in Capsule (EP-PIC), will be used to administer doses from 0.5 mg up to and including 56 mg of a single rising dose over 3 treatment periods receiving two doses of PF-04455242 and one dose of placebo. A one-week (minimum) washout will separate each treatment period.
DRUG	Placebo	PIC matching in appearance to PF-04455242 will be used to administer placebo.

Timeline

• Start date: 2009-04-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2009-07-13
• Last updated: 2009-10-16

Locations

1 site across 1 country: United States