NCT00938301

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
Last Updated

October 16, 2009

Status Verified

October 1, 2009

Enrollment Period

3 months

First QC Date

July 9, 2009

Last Update Submit

October 15, 2009

Conditions

Bipolar Depression

Keywords

healthy volunteer, first in human, safety and tolerability

Outcome Measures

Primary Outcomes (5)

  • Safety and tolerability of single doses will include neurological assessment, vital signs and adverse event reporting during inpatient stay.

    Daily

  • Physical exam

    Screening, End of Trial (EOT), and Follow Up (F/U)

  • Clinical safety laboratory results

    Screening, Day 0 (D0), D2, F/U

  • 12-lead ECGs

    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) .

    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 (1)

  • 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

Study Arms (2)

Treatment

ACTIVE COMPARATOR

2 cohorts will recieve single rising doses of PF-04455242 or placebo in a cross-over fashion.

Drug: PF-04455242

Placebo

PLACEBO COMPARATOR

2 cohorts will receive single rising doses of PF-04455242 or placebo in a cross-over fashion.

Drug: Placebo

Interventions

PF-04455242DRUG

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.

Treatment
PlaceboDRUG

PIC matching in appearance to PF-04455242 will be used to administer placebo.

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511-5473, United States

Location

Related Links

MeSH Terms

Conditions

Bipolar Disorder

Interventions

2-methyl-N-((2'-(pyrrolidin-1-ylsulfonyl)biphenyl-4-yl)methyl)propan-1-amine

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 9, 2009

First Posted

July 13, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

October 16, 2009

Record last verified: 2009-10

Locations

US(1)