Back to resultsA First In Human Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Single Rising Doses In Healthy Adult Volunteers
Primary Purpose
Bipolar Depression
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-04455242
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Depression focused on measuring healthy volunteer, first in human, safety and tolerability
Eligibility 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.
Sites / Locations
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Treatment
Placebo
Arm Description
2 cohorts will recieve single rising doses of PF-04455242 or placebo in a cross-over fashion.
2 cohorts will receive single rising doses of PF-04455242 or placebo in a cross-over fashion.
Outcomes
Primary Outcome Measures
Safety and tolerability of single doses will include neurological assessment, vital signs and adverse event reporting during inpatient stay.
Physical exam
Clinical safety laboratory results
12-lead ECGs
Maximum plasma concentration (Cmax), time to reach maximum concentration (Tmax), area under the concentration-time curve (AUC) and terminal half-life (t1/2) .
Secondary Outcome Measures
Likert and Drug Effect Questionnaire (DEQ) questionnaires
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00938301
Brief Title
A First In Human Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PF-04455242 In Single Rising Doses In Healthy Adult Volunteers
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 Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
healthy volunteer, first in human, safety and tolerability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Active Comparator
Arm Description
2 cohorts will recieve single rising doses of PF-04455242 or placebo in a cross-over fashion.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
2 cohorts will receive single rising doses of PF-04455242 or placebo in a cross-over fashion.
Intervention Type
Drug
Intervention Name(s)
PF-04455242
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
PIC matching in appearance to PF-04455242 will be used to administer placebo.
Primary Outcome Measure Information:
Title
Safety and tolerability of single doses will include neurological assessment, vital signs and adverse event reporting during inpatient stay.
Time Frame
Daily
Title
Physical exam
Time Frame
Screening, End of Trial (EOT), and Follow Up (F/U)
Title
Clinical safety laboratory results
Time Frame
Screening, Day 0 (D0), D2, F/U
Title
12-lead ECGs
Time Frame
Screening, D1, D2, F/U
Title
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 Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511-5473
Country
United States
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1071001&StudyName=A%20First%20In%20Human%20Study%20To%20Evaluate%20The%20Safety%2C%20Tolerability%20And%20Pharmacokinetics%20Of%20PF-04455242%20In%20Single%20Rising%20Doses%20In%20Healthy%20Ad
Description
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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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