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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Depression
Behavioral Symptoms

ClinicalTrials.gov processed this record on October 20, 2014