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

Phase 1

Completed

• Conditions: Bipolar Depression
• Interventions: Drug: PF-04455242; Drug: Placebo

• Registration Number: NCT00938301
• Lead Sponsor: Pfizer

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-04455242-01 in healthy adult volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-09
• Study First Posted: 2009-07-13
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-15
• Last Update Posted: 2009-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Treatment	PF-04455242	2 cohorts will recieve single rising doses of PF-04455242 or placebo in a cross-over fashion.
Placebo	Placebo	2 cohorts will receive single rising doses of PF-04455242 or placebo in a cross-over fashion.

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of single doses will include neurological assessment, vital signs and adverse event reporting during inpatient stay.	Daily
Physical exam	Screening, End of Trial (EOT), and Follow Up (F/U)
Clinical safety laboratory results	Screening, Day 0 (D0), D2, F/U
12-lead ECGs	Screening, D1, D2, F/U
Maximum plasma concentration (Cmax), time to reach maximum concentration (Tmax), area under the concentration-time curve (AUC) and terminal half-life (t1/2) .	0 hr (predose) then 0.5-1 hr for the next 12 hrs postdose on D1, then 24, 36, 48, & 72 hrs postdose

Secondary Outcome Measures

Name	Time	Method
Likert and Drug Effect Questionnaire (DEQ) questionnaires	0 hr (predose) then 1, 2, 3, 4, 6 ,8, & 12 hrs (postdose) on D1, then 24 hrs (postdose) on D2

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States