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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00938301

Purpose

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.

Condition	Intervention	Phase
Bipolar Depression	Drug: PF-04455242 Drug: Placebo	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Safety and tolerability of single doses will include neurological assessment, vital signs and adverse event reporting during inpatient stay. [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
Physical exam [ Time Frame: Screening, End of Trial (EOT), and Follow Up (F/U) ] [ Designated as safety issue: Yes ]
Clinical safety laboratory results [ Time Frame: Screening, Day 0 (D0), D2, F/U ] [ Designated as safety issue: Yes ]
12-lead ECGs [ Time Frame: Screening, D1, D2, F/U ] [ Designated as safety issue: Yes ]
Maximum plasma concentration (Cmax), time to reach maximum concentration (Tmax), area under the concentration-time curve (AUC) and terminal half-life (t1/2) . [ Time Frame: 0 hr (predose) then 0.5-1 hr for the next 12 hrs postdose on D1, then 24, 36, 48, & 72 hrs postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Likert and Drug Effect Questionnaire (DEQ) questionnaires [ Time Frame: 0 hr (predose) then 1, 2, 3, 4, 6 ,8, & 12 hrs (postdose) on D1, then 24 hrs (postdose) on D2 ] [ Designated as safety issue: Yes ]

Enrollment:	18
Study Start Date:	April 2009
Study Completion Date:	July 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment: Active Comparator 2 cohorts will recieve single rising doses of PF-04455242 or placebo in a cross-over fashion.	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.
Placebo: Placebo Comparator 2 cohorts will receive single risking doses of PF-04455242 or placebo in a cross-over fashion.	Drug: Placebo PIC matching in appearance to PF-04455242 will be used to administer placebo.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938301

Locations

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511-5473

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B1071001
Study First Received:	July 9, 2009
Last Updated:	August 20, 2009
ClinicalTrials.gov Identifier:	NCT00938301 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

healthy volunteer, first in human, safety and tolerability

Study placed in the following topic categories:

Affective Disorders, Psychotic
Depression
Mental Disorders
Bipolar Disorder
Mood Disorders

Psychotic Disorders
Healthy
Depressive Disorder
Behavioral Symptoms

Additional relevant MeSH terms:

Affective Disorders, Psychotic
Depression
Mental Disorders

Bipolar Disorder
Mood Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 11, 2009