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
Overview
- Phase
- Phase 1
- Intervention
- PF-04455242
- Conditions
- Bipolar Depression
- Sponsor
- Pfizer
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Safety and tolerability of single doses will include neurological assessment, vital signs and adverse event reporting during inpatient stay.
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
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.
Arms & Interventions
Treatment
2 cohorts will recieve single rising doses of PF-04455242 or placebo in a cross-over fashion.
Intervention: PF-04455242
Placebo
2 cohorts will receive single rising doses of PF-04455242 or placebo in a cross-over fashion.
Intervention: Placebo
Outcomes
Primary Outcomes
Safety and tolerability of single doses will include neurological assessment, vital signs and adverse event reporting during inpatient stay.
Time Frame: Daily
Physical exam
Time Frame: Screening, End of Trial (EOT), and Follow Up (F/U)
Clinical safety laboratory results
Time Frame: Screening, Day 0 (D0), D2, F/U
12-lead ECGs
Time Frame: Screening, D1, D2, F/U
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 Outcomes
- Likert and Drug Effect Questionnaire (DEQ) questionnaires(0 hr (predose) then 1, 2, 3, 4, 6 ,8, & 12 hrs (postdose) on D1, then 24 hrs (postdose) on D2)