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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00938301
First received: July 9, 2009
Last updated: October 15, 2009
Last verified: October 2009
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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
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.

  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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00938301     History of Changes
Other Study ID Numbers: B1071001
Study First Received: July 9, 2009
Last Updated: October 15, 2009
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on April 17, 2014