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TerminatedNCT00939887Updated Feb 8, 2010

A Study Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET (Positron Emission Tomography)

A Phase 1 interventional study of PF-04455242 in Bipolar Disorder and Depression, sponsored by Pfizer. Terminated at 3 sites in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-02-08.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

Why this study was terminated
This study was terminated on January 6, 2010, due to toxicology findings in animals exposed to PF-04455242 for three months.
Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This is a subject blind, investigator and sponsor open, randomized study consisting of 2 parts. Up to 15 healthy subjects will be included in the study. In the first part of the study the test retest reliability of the radiotracer [11C] PF 04767135 binding in man will be assessed. In the second part of this study, using [11C] PF 04767135, kappa opioid receptor occupancy (RO) will be assessed in up to three cohorts of subjects.

02

Conditions studied

  • Bipolar Disorder
  • Depression
03

In context

Bipolar Disorder

1,637 studies on the registry are indexed under Bipolar Disorder; 258 are open to participants now.

This study's enrollment of 12 is below the median of 63 across 1,245 interventional studies indexed under Bipolar Disorder.

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Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.)

Exclusion criteria

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen at Screening or Day 0.
  • History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men.
  • Use of tobacco- or nicotine-containing products within 3 months of screening.
  • Treatment with an investigational drug within 30 days or 5 half lives preceding the first dose of study medication (excluding [11C]PF 04767135).
  • 12 lead ECG demonstrating QTc >450 msec at Screening.
  • Pregnant or nursing females; females of childbearing potential.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Single group
Masking
Single (Participant)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    Treatment

    Drug: PF-04455242

Interventions

  • DrugPF-04455242

    Single dose of up to 30 mg PF-04455242, delivered in capsule.

06

What researchers measure

Primary outcomes

  1. Overall kappa opioid receptor occupancy of PF 04455242.

    Time frame: Study Day 1 and 2

Secondary outcomes

  1. Binding potential (BP) of [11C] PF 04767135.

    Time frame: Study Day 1 and 2

  2. Kappa opioid receptor occupancy of PF 04455242 at regions of interest in man.

    Time frame: Study Day 1 and 2

  3. Relationship between plasma PF 04455242 concentration and kappa opioid receptor occupancy (IC50).

    Time frame: Study Day 1 and 2

07

Study locations

3 sites
  • Pfizer Investigational Site
    New Haven, Connecticut 06511-5473, United States
  • Pfizer Investigational Site
    New Haven, Connecticut 06519, United States
  • Pfizer Investigational Site
    New Haven, Connecticut 06520, United States
08

References and documents

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2009, a primary completion of Dec 2009 and a completion of Dec 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2009
First posted
Jul 15, 2009
Start
Sep 2009
Primary completionActual
Dec 2009
CompletionActual
Dec 2009
Last update
Feb 8, 2010
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00939887
Lead sponsor
Pfizer
First posted
Jul 15, 2009
Start date
Sep 2009
Primary completion
Dec 2009
Completion
Dec 2009
Last update
Feb 8, 2010

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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Discussion

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