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

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ClinicalTrials.gov Identifier: NCT00938301
Recruitment Status : Completed
First Posted : July 13, 2009
Last Update Posted : October 16, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Bipolar Depression Drug: PF-04455242 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : April 2009
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Treatment
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 Comparator: Placebo
2 cohorts will receive single rising 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.

Primary Outcome Measures :
  1. Safety and tolerability of single doses will include neurological assessment, vital signs and adverse event reporting during inpatient stay. [ Time Frame: Daily ]
  2. Physical exam [ Time Frame: Screening, End of Trial (EOT), and Follow Up (F/U) ]
  3. Clinical safety laboratory results [ Time Frame: Screening, Day 0 (D0), D2, F/U ]
  4. 12-lead ECGs [ Time Frame: Screening, D1, D2, F/U ]
  5. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938301

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511-5473
Sponsors and Collaborators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00938301     History of Changes
Other Study ID Numbers: B1071001
First Posted: July 13, 2009    Key Record Dates
Last Update Posted: October 16, 2009
Last Verified: October 2009

Keywords provided by Pfizer:
healthy volunteer, first in human, safety and tolerability

Additional relevant MeSH terms:
Bipolar Disorder
Bipolar and Related Disorders
Mental Disorders